Azzur Group Jobs

The Director of Quality Assurance will oversee the quality systems and standards for the organization, ensuring that all products meet regulatory requirements and internal specifications. This leadership role is critical to maintaining our commitment to excellence and compliance throughout the product lifecycle. This position aims to monitor and improve a quality management system, maintaining compliance with established standards and agency guidelines. SUMMARY OF RESPONSIBILITIES: Act as a Management Representative, as needed. Implement the necessary changes in the quality system for improvements and maintain compliance with established standards. Maintain quality assurance programs, policies, processes, procedures, and controls, ensuring that the performance and quality of the products conform to established standards and agency guidelines. Provide leadership for quality systems improvements and business process improvement initiatives. Responsible for providing adequate support for creating and preparing documentation that is required by the regulatory department for global registration submissions and approvals to introduce new products in the US, EU, Canada, Australia, and other jurisdictions for Class I, II devices, NHPs, and drugs. KEY RESPONSIBILITIES: Act as a Management Representative, as necessary. Report to VP of QA/RA and Mfg. Be responsible for the performance of the quality management system and address any need for improvement. Ensure the promotion of awareness of regulatory and customer requirements throughout the organization. Oversee generation and review of documents used in good manufacturing practices and monitor audits of production and quality control areas. Provide expertise and guidance in interpreting governmental Quality regulations, agency guidelines, and internal policies to ensure compliance and effectiveness. Manage document control and oversee related quality systems such as training and other electronic quality systems to ensure effectiveness. Participate with peers in formulating overall direction, processes, systems, and talent development for the QA organizations. Provide adequate support for document preparation for global regulatory submissions, including but not limited to the FDA 510(k), technical documentation for medical devices and dossiers for drugs, Canadian medical device, NHP and drug license applications, internal "Letters to File", etc. Assess device labeling and advertising materials for compliance with global regulations; analyze and recommend appropriate changes. Review and sign off on product and manufacturing changes for compliance with applicable regulations. Review, assess, and approve product documents, including but not limited to the design and manufacturing changes and labeling. Review and approve test protocols to support regulatory submissions. Oversee Risk Management and provide input in design verification, design validation and shelf-life studies. Provide technical guidance and training / mentoring to other QA employees and cross-functional teams. Develop and implement departmental goals, policies, and procedures. Monitor industry trends and regulatory changes to ensure that company practices remain compliant and competitive. Other duties as assigned. KNOWLEDGE / EDUCATION Bachelor's degree in science minimum. (Master's degree in science preferred). Knowledge of the FDA medical device and drug regulations, guidance, and import / exports requirements. Knowledge of European Medical Regulations (MDR). Knowledge of medical device labeling and promotional requirements. Strong understanding of the quality system regulations. Thorough knowledge of product development process, design control and Quality System. Strong technical knowledge of medical devices and OTC Drug products. Strong technical understanding of relevant procedures, practices, and medical terminology. JOB EXPERIENCE At least 10 years of experience in the medical industry as a Director or Senior Manager of Quality Assurance. At least 10 years of experience managing/leading a team. Demonstrated success in Quality Management. Demonstrated management skills and experience. Experience developing a team and individuals Knowledge of or experience in Risk management. Knowledge of QS regulations preferred. Statistical analysis and problem-solving abilities are strongly preferred. Demonstrate extensive experience with the FDA, ISO 13485, and Notified Body inspections SKILLS / COMPETENCIES Proficient in timely review of technical and clinical data. Proficient in FDA and international regulations (e.g., EU and Canada) Technical knowledge of medical devices (class I and II) and drugs. Ability to write clear, concise, and well-thought-out technical documents. Good presentation skills. Strong communication skills Ability to perform well in stressful or time-sensitive situations Able to manage complex problems/projects by exercising independent decision-making and analytical thinking skills, with minimal supervision Computer skills: MS Word, PowerPoint, MS Project, Adobe Acrobat, Excel, graphics presentation etc. Strong leadership, organizational, interpersonal, and influencing skills Strong written and oral communication skills Detail-oriented and self-motivated. Ability to work well with team members and clients Ability to exercise judgment in selecting innovative, practical methods to achieve problem resolution. Excellent negotiation skills. Ability to work under minimal supervision and independently. Must be able to deliver high-quality work in a tight-timeline-driven environment. Strong leadership, interpersonal and influencing skills. Ability to be flexible and adjust to changing circumstances. This is a full-time, on-site role based in our Santa Rosa Headquarters. Must be available to work 5 days per week, one Saturday per month and as needed per business requirements. BENEFITS Competitive salary bonus potential Relocation support as needed Health benefits including medical, dental and vision coverage for employee and family 401(k) with 4% match 2 weeks paid vacation 6 paid holidays Sick days per California law

Tri-Pac, Inc., a contract development and manufacturing organization (CDMO) specializing in liquid and aerosol filling for personal care and pharmaceutical industries, is seeking an experienced Executive Assistant to join our fast-growing team in South Bend, Indiana. The ideal candidate will provide high-level administrative support to senior executives, managing a variety of tasks with professionalism and attention to detail. This role requires excellent organizational skills, the ability to manage complex schedules, and the ability to draft documents and assist with meeting preparations. Executive Assistant Duties: Manage administrative tasks for senior management, including coordinating schedules and meetings. Prioritize and manage high-volume email correspondence, flagging urgent matters. Review and prepare documents for Directors' approval and ensure timely follow-up. Organize meetings, prepare agendas, and handle logistics, including catering for luncheons and meetings. Compile, transcribe, and distribute minutes from meetings. Generate complex reports, ensuring data accuracy and clarity. Conduct research and prepare materials for executives, committees, and board meetings. Maintain confidentiality while managing sensitive information and prioritizing key issues. Perform general office tasks, including ordering supplies, maintaining records, and basic bookkeeping. Develop strong relationships with internal and external stakeholders. Greet visitors and determine appropriate access to executives. Review and recommend improvements to office procedures and workflows. Submit expense reports and assist with special projects as assigned. Requirements: CONFIDENTIALITY Bachelor's degree in Business Administration, Accounting, or Science. 7+ years of executive administrative experience in a corporate setting. Legal knowledge related to compliance, including Non-Disclosure Agreements (NDAs). Proven experience supporting senior leadership teams. Ability to work independently or collaboratively with minimal supervision. Comfortable in a fast-paced, dynamic environment. Excellent organizational, time-management, and interpersonal skills. Proficiency in Microsoft Office Suite and SAP. Strong written and verbal communication skills. Responsibilities: Manage executive calendars and assist in meeting preparation. Respond to emails and document requests on behalf of executives. Draft presentations, meeting notes, and documents for executives. Qualifications: Bachelor's degree or equivalent experience. Proficient in Microsoft Office Suite. Proven experience in managing multiple priorities and coordinating logistics. Detail-oriented, well-organized, and skilled in multi-tasking with excellent follow-up. Strong written and verbal communication skills. Benefits: At Tri-Pac, Inc., we offer a competitive salary and a comprehensive benefits package, including unlimited PTO, insurance, 401K, life insurance, and both short- and long-term disability. We are committed to your personal and professional growth through continuous training and education assistance. Visit us at: ************** Thank you for considering a career with Tri-Pac, Inc. Tri-Pac, Inc. is an Equal Employment Opportunity / Affirmative Action Employer. For Staffing & Recruitment Agencies: Please note that we do not accept unsolicited CVs or applications from agencies. We are not responsible for any fees related to unsolicited submissions and retain the right to contact candidates presented through such channels.

The Quality Assurance (QA) Engineer II will play a key role in the implementation of Onkos Surgical's Quality Management System and have the opportunity to gain experience across a broad range of quality functions related ISO 13485 and 21 CFR Part 820 compliance. Specifically, the QA Engineer will champion complaint handling, product release procedures and approval, and support to both NCR and CAPA processes. This will require developing relationships and working closely with suppliers. This position will also work with cross-functional teams to provide quality engineering support in the development of technical files to ensure regulatory compliance during product development. Responsibilities Receive, document and process complaints related to product quality and patient safety. Conduct, coordinate and document complaint investigations. Review complaints for possible Adverse Events/MDRs and recommend regulatory reporting decisions. Prepare reports to regulatory agencies in a timely manner to meet regulatory deadlines. Review and approve Device History Records (DHRs) and communicate closely with contract suppliers to ensure compliance with Quality Agreements and QMS procedures. Participate in and support NCR and CAPA investigations. Participate in the application of statistical methods to trend NCRs, CAPAs, Complaints, and DHR approval acceptance. Support in Supplier vetting process and maintaining Approved Supplier List. Provide support to Product Development and Operations on design transfer and process validations. Participate in product risk assessment efforts, including failure mode effect analysis (FMEA's). Monitor quality metrics and key process indicators to identify opportunities. Lead and/or participate in multi-departmental initiatives to implement quality improvements. Drive compliance to the QMS and provide QMS training to appropriate team members. Author changes to existing procedures, work instructions, and forms as necessary. Comply with U.S. FDA and ISO requirements, other regulatory requirements, Company policies, operating procedures and processes. Perform other QA and quality control functions as necessary, with appropriate training. Assist in the review of Technical Files. Requirements Minimum of 5 years quality assurance experience in medical device industry. Manufacturing or supplier quality engineering experiences a plus. Working knowledge of CFR Part 820 and 13485 for medical device products. Complaint investigation experience. BS in an engineering discipline. Certified Quality Engineer certification a plus. Experience in root cause failure analysis and change control. Detail oriented and experience in a manufacturing environment a plus. Good verbal (including presentation) and written communication skills. About Onkos Surgical At Onkos Surgical, we believe individuals with cancer requiring surgery deserve solutions designed specifically for them. These individuals, their caregivers and their support network deserve an organization passionately championing their cause. We exist to maintain a singular focus on surgical oncology by looking at everything we do through the lens of the cancer surgeon and their patients. At Onkos Surgical, we will: Find solutions to our patients' unmet clinical needs and advocate for their cause. Partner with surgical oncologists through research, education and innovation, to treat their patients more effectively and more efficiently. Collaborate with regulatory agencies to find pathways to provide timely solutions while upholding the highest standards of quality or compliance. Fulfill our employees' desire to make a difference in the lives of the patients they serve while achieving their own professional growth. Deliver value to our customers and shareholders.

Why The Botanist? The Botanist is a subsidiary of Canopy USA, LLC, a leading vertically integrated, multi-state operator in the United States cannabis industry. With the transition of Acreage Holdings to Canopy USA, LLC in December 2024, Canopy USA, LLC is now positioned to consolidate operations across its three business units - Wana, Jetty, and Acreage - realizing synergies, cost savings, and supporting growth in state-legal markets across the U.S. Through coverage of key market segments including flower via Superflux, vape and concentrates via Jetty, edibles and beverages via Wana, and retail through The Botanist, Canopy USA, LLC is well positioned to accelerate growth with an emphasis on the Midwestern and Northeastern U.S. markets. As newly formed Canopy USA, LLC, we are building a stronger, more agile organization that will unlock greater opportunities across the growing US cannabis market. Who you'll work for: The Botanist Our Culture: Here at Canopy USA, LLC, we believe in people first. We value our people and encourage continuous opportunities to learn, develop, and grow. We pride ourselves in innovation and passion for the cannabis industry. We are always looking for motivated people who share our vision to join our team. Think you have what it takes? Then come grow with us! About the Role ( Facilities Technician) : The Facilities Technician provides the daily care and focused attention necessary to maintain a clean, efficient and operational environment within the facility and is responsible for maintenance, repairs, and sanitation in the direction of the Facility Manager. How you'll make a difference (required duties and responsibilities) : Perform minor repairs of all buildings and equipment with minimal supervision.?? Perform major repairs at the direction and under the supervision of the manager. Major repairs may include working alongside and coordinating with external contractors or licensed tradesmen. Repairs can include emergency situations and/or scheduled repairs.? Responsibly use and/or operate vehicles, tools, materials, parts, maintenance supplies and equipment when necessary and ensure that they are used safely, effectively, and efficiently.? Install and maintain new equipment (assembling racks, installing dehumidifiers, etc.) in the direction of the manager. Follow maintenance and repair schedules set forth by the manager and ensure routine maintenance is performed in a timely and efficient manner.? Responsible for daily sanitation procedures including bathrooms, hallways, break areas, and anything inside/outside of the facility in coordination of the Sanitation Department.?? Restocks all PPE, trash, and restroom supplies throughout the building in coordination with the Sanitation Department? Maintains accurate records of repairs, equipment cleaning, maintenance and calibration and any other facility systems related to logs assigned by the manager. Promptly reports any system failure, malfunction, or facility damage to the manager Assist the manager with the completion of daily, weekly, and monthly checklists on building equipment, and maintenance procedures? Assist in the completion of secondary Facilities tasks at the direction of the manager according to company needs. Follow all aspects of the workplace safety program, biosafety program, and maintain compliance with all rules and regulations. And maintain a clean and safe environment on the production floor.??? May help in other departments as needed/Other duties as assigned.? Skills to be Successful (minimum qualifications) : High school diploma or equivalent Ability to prioritize tasks?? Ability to function well in a high-paced and at times stressful environment?? Meticulous organizational skills and attention to detail?? Interpret and follow complex, written, verbal and technical instructions?? Must be able to adhere to facility SOPs?? Learn complex technical procedures in a timely manner? Perks & Benefits: Full suite of medical, dental, and vision insurance Paid parental leave. 401 (k) Paid Time Off Short Term and Long-Term Disability Employee Assistance Program Employee life insurance and supplemental life Spouse and child life and ADD&D Pet insurance FSA and HSA are available. *Based on eligibility. Work Environment and Physical Demands: The work environment characteristics and physical demands described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be requested to enable individuals with disabilities to perform the essential functions. Must be able to work quickly but efficiently, while maintaining the integrity of the product. Light to moderate lifting of up to 50 lbs; heavier weights with assistance. Must be able to stand for prolonged periods of time. Repetitive motions and understanding of lab equipment. Must wear company-provided lab coats, hair/beard nets, gloves, surgical masks and safety glasses/ goggles/ splash shield, while working in the lab. Must adhere to facility general hygiene requirements. Capacity to stay focused on the task at hand. DISCLAIMER: This job description is designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to confirm or be interpreted as a comprehensive summary of all duties, responsibilities and qualifications required of employees assigned to this job. E-Verify Participation Notice This Employer participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. What is E-Verify? E-Verify is an internet-based system that compares information from and employee's Form I-9, Employment Eligibility Verification, to data from the U.S. Department of Homeland Security and Social Security Administration records to confirm employment eligibility. Code of Conduct: All employees are expected to represent value and maintain the standards contained in the Code of Conduct. The Botanist is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, disability, or protected Veteran status. We appreciate your interest in The Botanist . If you need assistance with completing an online application due to a disability, please send a request to **************************. Please be sure to include “Accommodation Request” in the subject line.

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers. About BioLife Plasma Services Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will report to the Plasma Center Manager and will perform as a Medical Support Specialist (Plasma Center Nurse) to support plasma center operations. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. About the role: Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will determine donor eligibility to donate plasma, management of donor adverse events, review of laboratory test results, and donor notification of unsuitable test results. The Medical Support Specialist (Plasma Center Nurse) works under the guidance of the Center Manager (or Assistant Manager as applicable) for operational guidance and under the management of the Center Physician for medical issues. The Medical Support Specialist will be familiar with regulations of the plasma collection industry or a manufacturing environment. The Medical Support Specialist follows guidance provided by BioLife Medical Affairs and provides center level support of environmental, health and safety (EHS). How you will contribute You will determine donor eligibility; to include, proper management of informed consent, AIDS education and confidential self-exclusion, medical history interview and acceptance requirements, physical examination, blood testing, and reviewing Serological Protein Electrophoresis (SPE). You will evaluate donor reaction(s), which occurs at the facility as outlined in the SOPs. Follow applicable SOPs for medical emergencies including the development of Center Physician's standing orders and donor transport to emergency care facilities. You will refer to the Center Physician or Medical Affairs (as applicable) when in need of providing unacceptable findings to donors, or guidance concerning medical or technical issues, including donor safety and eligibility. You will support the Hepatitis B and Seasonal Flu vaccination programs for employees as applicable. You will manage employee incidents and determine whether further evaluation is required by occupational health/ER. Refer to EHS guidance regarding employee incidents. You can be a Pandemic Coordinator when authorized by EHS and support investigations associated with pandemic threats within the local community as indicated by EHS or Medical Affairs. What you bring to Takeda: High school diploma or equivalent to including graduate equivalent of a recognized educational nursing program with state requirements Currently licensed or certified in the state where responsibilities will be assigned: Registered Nurse (RN), Nurse Practitioner (NP) or Physician Assistant (PA) Current Cardiopulmonary Resuscitation (CPR) and AED certification Fulfill state requirements (in state of licensure) for basic IV therapy Satisfactorily complete the FDA approved training requirements for BioLife Medical Support Specialist Two years in a clinical or hospital setting What Takeda can offer you: Every day at Takeda, we feel good knowing that what we do helps improve the lives of patients with rare diseases. At BioLife, while you focus on our donors, we will support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program to include medical/dental, paid time off and retirement benefits, all in a fast-paced, friendly environment. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to bring Better Health and a Brighter Future to people around the world. BioLife Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - CA - Pomona U.S. Hourly Wage Range: $38.08 - $52.36 The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. LocationsUSA - CA - PomonaWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt No

Medical Science Liaison- CNS (Chicago) Apply locations Remote time type Full time posted on Posted 2 Days Ago job requisition id R8704 Customer Engagement Model Otsuka America Pharmaceutical, Inc. has launched a new customer engagement approach designed to better deliver on patient, caregiver, and HCP needs in an evolving healthcare environment. The new model is built around where patients get their care-locally, with the intent to better serve patients, caregivers, and healthcare providers, delivering a higher quality experience that ultimately is focused on improving patient care. The local ecosystem approach creates a unified focus among account management, medical, patient access, and market access to engage local healthcare systems and identify opportunities to improve the patient experience. Through this matrix model, customers will now experience more coordinated and seamless care with digital-enabled support to bridge care gaps. In Otsuka's evolved customer engagement model, a Health Science Associates (HSA) will engage HCPs through a variety of in-person, virtual, and digital tools, offering expanded expertise regarding products and the approved conditions they treat. Otsuka's Clinical & Scientific Liaison (CSL) will provide deep clinical expertise on-demand and will engage healthcare providers to offer personalized education on disease state, thought leadership, and real-world evidence. A Patient Education Liaison (PEL) works to inform, educate, and enhance the experience of patients throughout their care continuum. The HSAs are led by Ecosystem Leads and grouped into regional areas. Ecosystem Leads are led by Regional Leads with significant autonomy to assess unique market priorities and customize decisions that reflect local customer needs. In the future, Otsuka will also be shifting to a team-based approach to drive customer engagement quality, accountability, and cohesion around patients and healthcare providers. Ultimately, it is all about putting customers at the center of everything they do. Position Overview - Medical Science Liaison As an integral member of the ecosystem team for Otsuka's new ecosystem-based customer engagement model, the Medical Science Liaison (MSL) contributes to the development of the ecosystem strategic business plan and identifies key stakeholders that are vital to the ecosystem. The Medical Science Liaison (MSL) is a credible partner responsible for providing clinical, scientific, and health economic information related to disease states and the appropriate utilization of approved Otsuka products within an ecosystem. This field-based position will engage with Key Influencers (KIs), Local Practice Leaders (LPLs), healthcare providers, and patient groups within their ecosystem to further patient outcomes aligned with the overarching objectives of Otsuka. In collaboration with their ecosystem partners, CSLs contribute to the customization of the region business strategy to meet local ecosystem needs and are responsible for the medical and educational requirements of their customers. In addition, CSLs may be responsible for covering multiple products within a therapeutic area, as well as engaging in broad clinical and scientific discussions that impact patient care, resulting in rich customer insights shared within the ecosystem. Key Activities and Responsibilities As part of the ecosystem team contributes a clinical and scientific perspective to the local execution plan that addresses ecosystem, and customer challenges, issues, and opportunities, to bring about improved patient care and outcomes. This extends to include coordination around execution of field activities. Build, cultivate, and leverage external relationships with key scientific and medical customers and organizations within their ecosystem to ensure strong understanding of evolving healthcare trends, disease state, Otsuka products, systems, and services across the ecosystem landscape, including KIs, LPLs, Key Decision Makers (KDMs), and Patient Advocacy. Maintain a comprehensive understanding of the ecosystem to ensure alignment with Otsuka's patient-centric strategy and priorities, including provision and delivery of optimal patient care. To be a credible source of evidence-based information that demonstrates the value of Otsuka and its products from the clinical, economic, and humanistic standpoint and works in partnership with providers, payers, and other key stakeholders to apply practical real-world solutions to improve patient outcomes. Build and cultivate important internal working relationships across the matrix team to ensure an enterprise approach when working with customers. Be accountable to regional Field Medical Affairs leadership to shape and execute on local medical strategies within planned timelines. Actively contribute to planning, content development, and dissemination of disease state information to customers in the field on a regular basis using the remote customer engagement platform. Disseminate disease state and healthcare landscape information to customers in the field on a regular basis utilizing remote customer engagement platform. Responsible for delivering the training and evaluation of promotional and disease state speakers. Serve as part of Otsuka's internal speaker bureau in support of product educational needs across the ecosystem. Collect and submit medical insights that drive decision making and prioritization of evidence generation efforts and healthcare solutions, including sharing at the local ecosystem level. Assist with Otsuka's clinical trials program, including registrational, post-marketing and Investigator-Sponsored Trials (ISTs), health economic outcomes research, and other specific medical collaborations; provide clinical expertise and feedback regarding operational management of clinical trials to ensure optimal site selection and performance. Support other areas of the organization including Safety & Pharmacovigilance for investigation of safety-related issues, Sales Training medical education on an ongoing basis including new hire and POAs, and the Field Medical Center of Excellence for mentoring and sharing of best practices. Qualifications Advanced degree in Pharmacy, Medicine, Biological Sciences, Health Services Research, or Public Health (PharmD., M.D., PhD. or D.Ph.) is required. Relevant therapeutic area knowledge is required. Understanding of the interconnectivity of health systems, overall delivery of patient care and experience working with healthcare professionals and other decision makers. Minimum of 3-5 years related work experience (clinical, health system or industry). Outstanding business acumen; knows the industry, Otsuka's business model and value proposition, key competitors, and other marketplace factors/dynamics. Able to identify solutions with the overall goal of improved patient outcomes. Excellent communication and collaboration skills; exhibits professional maturity, confidence, and competence. Strong conflict resolution skills: proven ability to achieve conflict resolution effectively and quickly with affected parties and work in a cross-functional environment. Knows how to summarize and communicate complex information and business objectives in a concise and effective way during presentations and other interactions. Understanding of industry legal, regulatory, and compliance landscape. Ability to work in an ambiguous environment undergoing transformation. Demonstrates behaviors aligned with the Otsuka Corporate Brand including Perseverance, Unconventional Thinking, and Humility. Business travel, by air or car, up to 70% of time depending upon size of ecosystem. Territory includes: Northern IL, WI, Upper Peninsula of MI. Preferred living location is Milwaukee area. Competencies Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business. Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders. Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. Respectful Collaboration - Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. Empowered Development - Play an active role in professional development as a business imperative. Minimum $146,955.00 - Maximum $210,100.00, plus incentive opportunity: The range shown represents a typical pay range or starting salary for candidates hired to perform the work. Other elements may be used to determine actual salary such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. This information is provided to applicants in accordance with states and local laws. Company benefits: Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************** Disclaimer: This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request. Statement Regarding Job Recruiting Fraud Scams At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc., and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************** Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************** or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. #J-18808-Ljbffr

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Senior Operations Management Trainee (Senior OMT) About BioLife Plasma Services Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment. Are you a senior leader interested in bringing your expertise to a place where you can feel good about the work you do? Do you want to develop new skills and set yourself up for continued growth? As a Senior Operations Management Trainee at BioLife, you will participate in an advanced leadership development program that will take you to our plasma centers across the country. You'll travel up to 95% of the time to learn the business while networking with supportive leaders and prepare yourself for accelerated career growth. After completing the program and obtaining a Plasma Center Operations Manager role, you'll relocate to one of BioLife's locations. Our growth is your bright future. Opportunities to grow as a leader are within your reach. With the incredible growth of 135+ BioLife Plasma Services centers across the U.S., the future looks bright for you. When you work at BioLife, you'll feel good knowing what you do makes a difference. A typical day for you may include: Continuous Learning & Development: The expedited training program lasts approximately six months. Upon completion, you'll have 12 months to obtain a Plasma Center Manager position. During this time, you'll receive hands-on experience and have mentorship opportunities. Drive your own learning plan that covers all aspects of managing our high-volume blood plasma collection facilities. Team Management: You'll use your interpersonal and communication skills to cultivate a positive environment and motivate a team of diverse individuals. Provide employee feedback, conduct performance reviews, support team members' development, participate in staff planning and recruiting, and engage and retain employees. Career Advancement: Work towards obtaining a Plasma Center Operations Manager position by completing the training program, networking, and building relationships across BioLife. As you progress your career at BioLife, you'll have opportunities to open and operate brand new plasma centers. Supportive Teamwork: You'll work in our fast-paced, team environment; provide operational support; conduct management training; problem-solve; and communicate with senior management. Exceptional Customer Service: Retain donors by creating a positive donor experience. You may also assist with production. Travel Opportunities: Learn from and network with BioLife team members across the country. You'll be able to return home every other weekend. REQUIRED QUALIFICATIONS: Relocation Required upon graduation/completion of Trainee Program. You will be able to choose which location you would like to apply to. 3-5 years of experience leading medium to large teams (20+ direct reports) Up to 90-100% travel during the Trainee Program Ability to walk and/or stand for the entire work shift Willingness to travel and work at various BioLife locations across the country Ability to work evenings, weekends, and holidays Have a valid driver's license for the entire duration of the program Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees Ability to lift up to 5 lbs., and occasional lifting of materials up to 32 lbs. and rarely 50 lbs. Fine motor coordination, depth perception, and ability to hear equipment from a distance Due to potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear PREFERRED QUALIFICATIONS: Associates or Bachelor's Degree Experience working with SOPs, GDP, GMP, CLIA, and the FDA Experience working in a highly regulated or high-volume retail environment Excellent interpersonal, organizational, technical, and leadership skills BioLife Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. W e are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - IL - Virtual U.S. Base Salary Range: 77 700.00 The estimated salary range reflects an anticipated range for this position . T he actual base salary offered may depend on a variety of factors , including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained , certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based e mployee s may be eligible for s hort -t erm and/or l ong- t erm incentiv e s . U.S. based employees may be eligible to participate in medical, dental , vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations USA - IL - VirtualUSA - IL - Addison, USA - IL - Bolingbrook, USA - IL - Chicago, USA - IL - RockfordWorker Type EmployeeWorker Sub-Type RegularTime Type Full time Job Exempt Yes

Strategic Brand Marketing Manager - Pharmaceuticals Located in the vibrant city of San Francisco, California, we are seeking an experienced Strategic Brand Marketing Manager to join our dynamic pharmaceuticals company. This position plays a crucial role in shaping our brand strategy and ensuring cohesive cross-collaborative efforts among Sales, Medical Affairs, and Commercial teams. Key Responsibilities: Develop and execute innovative marketing strategies tailored to the life sciences sector. Collaborate effectively with Sales, Medical Affairs, and Commercial teams to align on brand vision and goals. Leverage market insights to drive brand growth and market share. Conduct market research and competitive intelligence to assess the evolving landscape and identify opportunities for growth. Analyze key metrics to refine marketing strategies, monitor brand performance, and adapt tactics to improve results. Assist in the execution of marketing programs and activities to support the brand's presence in the market. Required Skills: EPM: Utilize Enterprise Project Management skills to oversee major brand projects from conception through execution. Brand Management: Demonstrated experience in managing brands within the pharmaceuticals sector, ensuring alignment with corporate objectives. Strategic Thinking: Ability to think critically and strategically about long-term brand positioning and day-to-day operational challenges. Experience in cross-functional collaboration, with the ability to influence stakeholders and drive brand objectives. A Bachelor's degree in Marketing, Business, or a related field is required; an MBA or advanced degree is preferred. Position Details: This is a permanent role offering a competitive salary range of $130,000-$150,000k base plus bonus. The position requires three days per week on-site presence in San Francisco. Candidate Profile Ideal candidates will have at least 3 years of relevant experience in life sciences brand marketing. Strong analytical skills and a proven track record in strategic planning and cross-functional collaboration are essential.

Kelly Services is excited to partner with Johnson & Johnson, a global leader in the medical device industry. We are seeking a highly organized and detail-oriented Administrative Support Specialist to support R&D initiatives in Irvine, CA. This role is ideal for candidates with strong administrative and project coordination capabilities, particularly in supporting cross-functional teams, managing documentation, and streamlining operational processes. Position Title: Administrative Support Specialist Schedule: 8AM-5PM Monday-Friday Compensation: $38 to $45 per hour (based on experience and qualifications) Benefits: Comprehensive Benefit Package Location: Irvine, CA Who We're Looking For: We recognize that candidates may not meet every single requirement. If you have a strong administrative background, excellent organizational skills, and a proactive approach to problem-solving, we encourage you to apply. Training will be provided in areas where development is needed. Key Responsibilities: Provide administrative and project coordination support to R&D teams. Maintain and organize documentation, including Device History Files and compliance records. Assist in budget tracking, purchase order reconciliation, and vendor management to ensure financial alignment. Coordinate contracts and logistics for healthcare professionals (HCPs) and research engagements. Support new product development activities, including material sourcing, supply chain coordination, and design control for development builds. Contribute to process improvement initiatives related to compliance, cost efficiency, and business continuity. Manage project communications, facilitate meetings, and provide regular updates to stakeholders. Utilize enterprise systems such as PLM systems, Totality, JDE, ARIBA, and Windchill to support project tracking and documentation. Qualifications: Bachelor's degree in a relevant field with 4-6 years of experience (or an Associate's degree with 6+ years of experience). Strong administrative and organizational skills, with experience in project coordination or support. Proficiency in MS Office Suite and enterprise systems (PLM, JDE, ARIBA, Windchill, etc.). Ability to multi-task, meet deadlines, and work in a fast-paced environment. Excellent communication skills, both written and verbal. Prior experience in medical devices, R&D, or product development is preferred but not required. Familiarity with financial tracking, supply chain coordination, and documentation management is a plus. Join a Leader in Medical Innovation At Johnson & Johnson, you'll have the opportunity to work on impactful projects that contribute to the advancement of healthcare. This is a chance to be part of a collaborative and innovative team that values professional growth, creativity, and teamwork. Apply today by submitting your resume for immediate consideration! Thank You, Kelly Services

Contracted Licensed Physician ESSENTIAL JOB FUNCTIONS: To provide independent medical judgment and discretion regarding donor safety, health, and suitability for plasmapheresis and/or immunization. The ideal candidate will demonstrate the ability to supervise medical staff and ensure compliance with federal and international regulations, as well as internal standard operating procedures. Donor Interaction Ensure donor satisfaction through oversight of physician substitute interactions and responsiveness to donor needs. Select suitable plasmapheresis donors according to medical education, experience, and compliance with Standard Operating Procedures (SOP), FDA, OSHA, Clinical Laboratory Improvement Amendments (CLIA), and current Good Manufacturing Practices (cGMP), including informed consent administration and medical history assessment. Consultation Availability Provide on-site, telephone, or electronic consultation regarding donor eligibility. Informed Consent Explanation Ensure detailed explanations of informed consents for plasmapheresis and immunization are provided to donors in compliance with applicable federal regulations. Donor Inquiry Response Supervise physician substitutes in addressing donor questions and ensuring that donors are given a clear opportunity to refuse participation. Physical Examinations Oversee the performance of physical examinations and analyze accumulated data to confirm established donor eligibility promptly. Medical Oversight Provide oversight to ensure that physician substitutes assess unusual or severe donor reactions with appropriate medical judgment. Training Requirements Deliver federal and internationally mandated training for donor center medical staff, including Physician Substitutes and Alternate Physicians. Management of Donor Reactions Exercise medical judgment to assess donor reactions and implement appropriate management procedures in line with current SOPs. Confidential Counseling Ensure that confidential counseling is provided to unacceptable donors, when applicable. Lab Result Review unusual or abnormal lab results, exercising independent judgment to determine future eligibility for donation. Service Delivery: Determine the method and means for the performance of contracted services in accordance with applicable regulations and client requirements. Education Specifications Must be a graduate from a licensed medical or osteopathic school. Must hold a current medical license in the state where the center operates. Must be approved by the state licensing agency as the CLIA Laboratory Director, Clinical Consultant, and Technical Consultant for the donor center, as applicable.

in Ridgefield, NJ 3 openings with different shifts Main Responsibilities: Conduct QA Shop Floor Walkthrough and Audit based on schedule and assignment Documentation of appropriate findings and support area improvement Support the Lead and Manager to drive QA shop floor program and address concerns with manufacturing and driving quality improvements Mentoring and coaching QA Shopfloor personnel Coaching manufacturing team, when required Collaboration with manufacturing on process improvements Area/Line clearances, when requirerd Review documentation- BPRs, Logbooks Deviation support, when required Perform audits, walk-throughs, GEMBAs, technical coaching Support Lead and Manager with tasks as needed (Change Control, Deviations etc) Support Additional Quality functions (Media Fill Observer, Documentation Updates etc) Basic Qualifications/Requirements: Bachelor's Degree in Life Sciences or Engineering 2-3 years' experience in a cGMP controlled/ pharmaceutical industry with a demonstrable working knowledge of contamination control, aseptic processing, cGMPs and regulatory requirements. Or 3 years or more of relevant experience in lieu of degree Must have Aseptic Manufacturing and Quality Auditing Experience Has experience with Filling machines in Grade A Worked in a Microbiology laboratory or Aseptic Production/Manufacturing Facility environment

The entry level Contract Analyst supports Red Oak Sourcing's contract related and data validation activities, primarily focused on contract maintenance and validation, in addition to data entry, auditing and data reconciliations. This position is within a fast-paced, collegial environment, providing the right individual with an opportunity for career advancement and the ability to directly interact with both parent organizations, Cardinal Health and CVS Health. **This is a hybrid role with a required schedule: onsite in our Foxboro, MA location on Tuesday, Wednesday, and Thursday, and remote on Monday and Friday. Relocation is not available for this position.** Responsibilities Timely and accurate execution of contractual activities including contract preparation, validation, contract execution, audits, document retention and related reporting Work cross functionally with both internal and external business partners to process and monitor the loading of contracts Data entry and system maintenance associated with contracts within Red Oak Sourcing's internal custom applications and Microsoft Azure Data Platform Contract and formulary management ensuring alignment and coordination with both Cardinal Health and CVS Health Super User/System Administrator of content management system (Contract Logix) Identification and reporting of any system issues to our third-party consulting partner Own and manage all changes to Data Validation SOPs, communicate changes as applicable, internally and to the parent organizations Perform routine reconciliations of data feeds coming to Red Oak from Cardinal Health and CVS Health Analyze and troubleshoot issues as identified with reconciliations, and determine steps for resolution Work closely with IT to ensure daily data feeds are loaded and validated Must execute job functions in a fast-paced, dynamic environment with a high degree of accuracy Qualifications Bachelor's Degree in related field, or equivalent work experience preferred Demonstrated ability to manage multiple work streams Strong team player with solid communication skills Strong Microsoft Excel skills a plus

The Development Engineer leads or participates on teams responsible for the design and development of surgical implants and instruments from concept through launch. The focus of these development projects has a heavy emphasis on the individualized treatment of patients on behalf of a requesting surgeon. The role also encompasses implementation of improvements and value engineering to existing patient specific product offerings and services, support of the development of the quality system and other company initiatives. Responsibilities Adhere to Onkos Core Beliefs, Code of Business Conduct, all regulatory requirements and quality standards. Support company advocacy initiatives to help raise awareness of sarcoma and pediatric cancer and drive positive change that will impact the lives of cancer patients. Prepare and manage to comprehensive project plans, resource requirements, project budgets, timelines, etc. Interface with sales force, surgeons, and other stakeholders to understand customer needs in order to define design inputs, draft product performance requirements, and draft surgical techniques. Utilize CAD software to model designs and detail engineering drawings, optimizing designs for quality, manufacturability, inspectability, and cost. Facilitate manufacture of prototypes and test articles. Develop and execute product test plans ranging from early bench testing/prototype evaluation to final validation and verification. Partner with regulatory team to fulfill all requirements for regulatory submissions and reports. Generate design controls, risk management documentation, and other technical memos, conducting root cause and engineering analyses as necessary. Support quality, regulatory, and marketing initiatives that require engineering assistance, analyses and quantitative assessments of markets and products. Assist in developing innovative manufacturing and processing techniques and/or seek out new technologies for materials and processing through 3 rd party relationships. Consult with surgeons and sales force to identify potential solutions for difficult patient cases. Requirements Passion to find solutions to our patients' unmet clinical needs and to advocate for their cause. Bachelor's degree in engineering or life sciences discipline. Mechanical or Biomedical Engineering preferred. 5+ years of product development experience in the medical device field, preferably related to orthopedics. Experience working with surgeons on product design a strong plus. Ability to apply engineering principles to solve problems and develop new products and techniques. Demonstrated ability with CAD software. SOLIDWORKS preferred. Must be self-motivated, able to work independently, and thrive in a fast-paced dynamic environment. Strong attention to detail, interpersonal skills, and oral and written communication skills. Must be willing to attend and participate in cadaveric product evaluations and attend surgery for observation and/or technical support. Travel requirement up to 5%. About Onkos At Onkos Surgical, we believe individuals with cancer requiring surgery deserve solutions designed specifically for them. These individuals, their caregivers and their support network deserve an organization passionately championing their cause. At Onkos Surgical, we exist to maintain a singular focus on surgical oncology by looking at everything we do through the lens of the cancer surgeon and their patients. At Onkos Surgical, we will Find solutions to our patients' unmet clinical needs and advocate for their cause. Partner with surgical oncologists through research, education and innovation, to treat their patients more effectively and more efficiently. Collaborate with regulatory agencies to find pathways to provide timely solutions while upholding the highest standards of quality or compliance. Fulfill our employees' desire to make a difference in the lives of the patients they serve while achieving their own professional growth. Deliver value to our customers and shareholders.

Tri-Pac, Inc. a contract development and manufacturing company (CDMO) specializing in liquid and aerosol filling for personal care and pharmaceutical marketers, is seeking an experienced Formulation Chemist (Personal Care - Hair Care/ Skin Care) for immediate addition to our fast growing team. This position is in South Bend, Indiana. Primary Functions Develop and prepare personal care and/or skin care products. Development of aerosol and liquid formulations Understand the needs and restrictions of the customer and develop formulas accordingly. Prepare Specifications for all products developed. Maintain laboratory notebook, including critical processing details and observations. Multi-task to handle 10-15 projects a week. Monitor batch shelf-life stability Calibrate and validate all lab equipment. Conducts and tracks all required performance and stability tests, interprets, records and reports results. Up to date with industry and consumer trends A working knowledge of the global regulatory requirements Perform other duties as needed or assigned. While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak, type and move throughout the facility Requirements 2-5 years lab/formulation experience Aerosol and working knowledge of propellants required. Knowledge of Access, Excel, Word, Projects Attention to detail, organization and multi-tasking skills. Technical knowledge of chemicals and their functionality to develop and prepare personal care and color products. Knowledge and use of Brookfield viscometers, pH meter, pychnometers, mixers, hotplates Ability to understand processing procedures, fill weights, formula cost implications, ingredient lists, and OTC products in order to be well rounded in the capacity of formulation skills. Knowledge of OTC guidelines/monographs Global formulation skills Ability to utilize a computer, telephone, fax and copy machine as well as other general office equipment. Strong computer skills are required. Ability to utilize Brookfield viscometers, pH meters, pycnometers, mixers and hotplates. The physical requirements listed in this section include but are not limited to the motor/physical abilities and skills required of position in order to successfully undertake the essential duties and responsibilities of this position. Must be capable of using a keyboard for computer purposes. Self-motivated Customer focused and Quality Driven Benefits Competitive Salary/ Pay & Packages, Vacations, Insurance, 401K, Life Insurance, Disability (Long term/ Short term) and Continuous Training. Work where you are HAPPY! Tri-Pac, Inc. also recognizes the importance of continuing education and offers Education Assistance to our employees to encourage continued personal development and growth. *************** Thank you for your interest and consideration of a career with Tri-Pac, Inc. Tri-Pac, Inc. is an Equal Employment Opportunity / Affirmative Action Employer To Staffing & Recruitment Agencies: Our Company does not accept unsolicited CV's or applications from agencies. We are not responsible for any fees related to unsolicited CV's or applications and explicitly reserve its right to contact candidates presented in such unsolicited CV or application.

Title: Senior Lead Consultant, M&A Due Diligence Compliance About Us: This employee-owned multidisciplinary firm operates in 35 countries and leads in emerging technologies. They are committed to sustainable development and have successfully transitioned a significant portion of their workforce to renewable energy projects. Ranked among the top environmental consulting companies globally, they offer competitive compensation and substantial annual bonuses. Position Overview: Join our dynamic team to conduct environmental due diligence and compliance reviews for industrial sites, supporting exciting business transactions. This role offers fantastic opportunities to mentor junior team members and manage projects, all while working in a fast-paced, collaborative environment. Responsibilities: Conduct environmental due diligence reviews, including compliance reviews of industrial sites to support various business transactions. This includes desktop reviews, site visits, interviews with management or site personnel, historical information review, and preparation of Phase I Environmental Site Assessment reports consistent with ASTM standards or custom client-specific reports. Provide general environmental compliance support across various regulatory program areas, including hazardous waste, wastewater/stormwater, air emissions, chemical/spill prevention, and Community Right-to-Know regulations. Tasks may also include permit transfers and environmental reporting. Travel to facilities for site visits, both locally and non-locally. Support multiple projects and ensure high-quality standards on project deliverables. Assist in the development of junior team members, contribute to proposals and cost estimates, and manage certain projects. Qualifications: Minimum B.S. degree in a relevant engineering discipline (civil, environmental, chemical) or B.S./B.A. in a relevant science discipline (environmental science, geology, chemistry, physics, or biology). An advanced degree is desirable but not required. 5+ years of experience in performing Phase I ESAs and environmental compliance reviews for various types of industrial facilities. Additional experience in the investigation and remediation of contaminated sites, emerging contaminants, health and safety, and ESG is helpful. Demonstrated ability to perform Phase I ESAs and limited environmental compliance reviews of complex industrial sites, with the ability to travel on short business trips. Travel is typically of short duration (1-2 days) and may be local or throughout the USA. A driver's license and air travel are required. Accustomed to working in a fast-paced transactional environment, with the ability to handle multiple tasks simultaneously. Excellent written and oral communication skills, with the ability to distill complex EHS or other technical issues into terms clients can understand. Highly motivated, flexible, and willing to learn, grow, and actively contribute to the project team.

Hanwha Ocean is embarking on a journey to transition from a traditional shipbuilder to an Engineering, Procurement, Construction, Installation, and Operation (EPCI(O)) solution provider, offering products such as FPSO, FLNG, Offshore Renewables and other Floating Production Units. The Offshore Business Division recently expanded its global footprint by establishing a new Global Business Centers in North America and Europe with the intention of becoming a project-centric and client-driven business organization. This transformation aims to offer enhanced project execution and knowledge-driven operational models by bridging the upstream culture of three continents across Asia, Europe, and America. Summary The Project Manager has the overall responsibility to deliver the Project in accordance with both the contractual requirements and Hanwha Ocean (HO)'s internal requirements, reporting to the Project Sponsor, Head of Projects or project Director (if applicable). Accountabilities Lead the team inspiring others to achieve the project as per plan. Define and maintain the project organization, responsibilities and accountabilities. Ensure the team has the balance of skills and expertise required to deliver the Project. Manage communication and reporting across all internal Project members. Foster teamwork and cooperation within the Project and with stakeholders Team self-awareness and assessment addressing meeting effectiveness, communication effectiveness, process effectiveness and the team's behavior. Provide the leadership direction required to successfully deliver (initiate, plan, execute, control, and close-out) a Project. Lead the HSSE and Quality culture throughout the project. Own the Execution Strategy, Project Execution Plan, and Project Business Plan. Communicate the Project objectives/ targets to the Project team and stake holders. Be the primary focal point with the Client and manage the communications, reporting and relationship with the client. Challenge performance in all aspects of the Project. Optimize costs and manage project cash flow. Optimize revenues & ensure the Management of Change and Risk processes are followed. Ensure the contract baseline (costs, schedule, scope, regulatory, rely upon data, client obligations, acceptance criteria, notification requirements, insurance cover, obligations, liabilities etc.) is summarized and communicated to the Project team. Ensure that the Client is notified as soon as a change in scope is detected in accordance with the terms of the contract. KPIs (financial, schedule, safety, warranty, and quality). Client's satisfaction and production up time during the first year of operations Timeliness of Client Acceptance and Project Close out Warranty Period performance Ensure that the functional employees have the right (level of) competencies to enable both current/future business priorities & needs by providing developmental information to the relevant line managers. Provide regular (and timely) individual feedback, ensure performance issues are addressed promptly by the relevant line manager and promote a motivating working environment. Champion sufficient growth opportunities and development aligned with both current /future business priorities & needs. Champion and promote talent growth by pro-actively offering cross department /projects/RC's exposure and opportunities. Provide functional guidance on how to best allocated department/ team development budgets to maximize talent development for current/ future business priorities & needs. Champion appropriate employee time for development. Coach/ mentor employees, provide input for development action plans and engage in effective retention efforts. Proven increase in Behavioral and Functional competency levels in your functional area. Development plans are of good quality and in place for all functional employees. Succession and talent management plan for the relevant functional employees are available and up to date. Qualifications and Experience Minimum 10 years of technical procurement experience with track records in managing successfully packages / categories preferably in Oil & Gas industry Experience in package engineering, manufacturing, integration, inspection and test, commissioning is recommended Experience in managing relationships with internal stakeholders and vendors Leadership Organizational skills Communication skills Project management skills (planning, budget) Team management Time management skills Flexible and adaptable to operational changes Wide range of technical knowledge Negotiation skills Contract management skills Savings management Diversity and Inclusion Hanwha believes that diversity and inclusion are vital to our success. We believe that by embracing different ideas and approaches, we enhance our ability to deliver the best results for our employees, our environment, and ultimately our business partners and customers. We foster a culture where all colleagues are able to share their passions and ideas in order that we may collectively embrace and overcome the challenges in our industry, and work toward a brighter future. Hanwha is an Equal Opportunity / Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, age, or any other federally protected class.

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Senior Operations Management Trainee (Senior OMT) Are you a senior leader interested in bringing your expertise to a place where you can feel good about the work you do? Do you want to develop new skills and set yourself up for continued growth? As a Senior Operations Management Trainee at BioLife, you will participate in an advanced leadership development program that will take you to our plasma centers across the country. You'll travel up to 95% of the time to learn the business while networking with supportive leaders and prepare yourself for accelerated career growth. After completing the program and obtaining a Plasma Center Operations Manager role, you'll relocate to one of BioLife's locations. Our growth is your bright future. Opportunities to grow as a leader are within your reach. With the incredible growth of 135+ BioLife Plasma Services centers across the U.S., the future looks bright for you. When you work at BioLife, you'll feel good knowing what you do makes a difference. A typical day for you may include: Continuous Learning & Development: The expedited training program lasts approximately six months. Upon completion, you'll have 12 months to obtain a Plasma Center Manager position. During this time, you'll receive hands-on experience and have mentorship opportunities. Drive your own learning plan that covers all aspects of managing our high-volume blood plasma collection facilities. Team Management: You'll use your interpersonal and communication skills to cultivate a positive environment and motivate a team of diverse individuals. Provide employee feedback, conduct performance reviews, support team members' development, participate in staff planning and recruiting, and engage and retain employees. Career Advancement: Work towards obtaining a Plasma Center Operations Manager position by completing the training program, networking, and building relationships across BioLife. As you progress your career at BioLife, you'll have opportunities to open and operate brand new plasma centers. Supportive Teamwork: You'll work in our fast-paced, team environment; provide operational support; conduct management training; problem-solve; and communicate with senior management. Exceptional Customer Service: Retain donors by creating a positive donor experience. You may also assist with production. Travel Opportunities: Learn from and network with BioLife team members across the country. You'll be able to return home every other weekend. REQUIRED QUALIFICATIONS: Relocation Required upon graduation/completion of Trainee Program. You will be able to choose which location you would like to apply to. 3-5 years of experience leading medium to large teams (20+ direct reports) Up to 90-100% travel during the Trainee Program Ability to walk and/or stand for the entire work shift Willingness to travel and work at various BioLife locations across the country Ability to work evenings, weekends, and holidays Have a valid driver's license for the entire duration of the program Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees Ability to lift up to 5 lbs., and occasional lifting of materials up to 32 lbs. and rarely 50 lbs. Fine motor coordination, depth perception, and ability to hear equipment from a distance Due to potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear PREFERRED QUALIFICATIONS: Associates or Bachelor's Degree Experience working with SOPs, GDP, GMP, CLIA, and the FDA Experience working in a highly regulated or high-volume retail environment Excellent interpersonal, organizational, technical, and leadership skills About BioLife Plasma Services Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. Equal Employment Opportunity BioLife Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. W e are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - MA - Virtual U.S. Base Salary Range: 77 700.00 The estimated salary range reflects an anticipated range for this position . T he actual base salary offered may depend on a variety of factors , including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained , certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based e mployee s may be eligible for s hort -t erm and/or l ong- t erm incentiv e s . U.S. based employees may be eligible to participate in medical, dental , vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations USA - MA - VirtualUSA - MA - Attleboro, USA - MA - Medford, USA - MA - Worcester Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

RM Senior Manufacturing Engineering Equipment Technician page is loaded RM Senior Manufacturing Engineering Equipment TechnicianApply locations Palo Alto time type Full time posted on Posted 4 Days Ago job requisition id R8603 At Recor Medical, we are pioneering Ultrasound Renal Denervation (uRDN) therapy to treat hypertension, the leading cardiovascular risk factor in the world. With our Paradise uRDN System, we're on a mission to provide the millions of people who suffer from hypertension with a non-drug and minimally invasive option to lower their blood pressure. Join us on our journey and make a meaningful impact on the lives of people around the globe. Position Summary: This is a hands-on position which will provide leadership on equipment control and readiness for Recor manufacturing. Position reports to the Manager, Equipment Engineer. Responsibilities and Duties: Identify equipment control improvements and assist in their development to reduce cost and/or improve product yield. Implement these changes via Document Change Order (DCO) process. Identify, test, and implement replicate equipment and manufacturing aids to advance operations for scalability. Complete equipment maintenance in a timely manner, including: Performing preventive maintenance of production and R&D equipment. Performing or facilitating the calibration of production and R&D equipment. Reviewing calibration certificates to ensure proper calibration. Performing equipment repairs. Communicating, troubleshooting, and resolving equipment issues/failures. Complete equipment qualification as required for facility and manufacturing equipment. Document completion of activities in a compliant manner consistent with Good Documentation Practices. Design and/or assemble manufacturing aides and fixtures using hand and power tools. Maintain work area cleanliness and compliance with various safety, fire, and hazmat guidelines. Execute work in a manner compliant with FDA and ISO guidelines for medical device development and manufacture. Read and work from mechanical drawings with detailed instructions. Maintain compliance with all document and procedure training requirements. Requirements: Minimum five years' experience as a technician in a regulated environment. Detail-oriented with a focus on quality and accuracy. Experience with manufacturing and mechanical testing of product prototypes. Ability to follow established written procedures and manage priorities with minimum supervision. Good oral communication skills. Basic computer skills using Microsoft Outlook, Word, and Excel. Self-motivated and result oriented. Ability to lift and/or move up to 50 lbs. Salary Range: $40.77/Hr- $44.71/Hr (Annual Base Salary) The successful candidate's starting base pay will be determined based on job-related skills, experience, qualifications, work location and market conditions. The expected base pay range for this role may be modified based on market conditions. Equal Employment Opportunity At Recor Medical, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic. Respecting your privacy is an essential part of the Company's privacy program and we are committed to the proper handling of Personal Information collected or processed in connection with an Applicant's application for employment, a Contract Worker's work, or a Former Employee's employment at Recor. Refer to our Applicant, Contract Worker & Former Employee Privacy Policy for more detail information. #J-18808-Ljbffr

Azzur Group is a GxP compliance and consulting organization focused on providing quality-driven solutions that propel life science companies toward success. If you're a dedicated professional with a desire to engage, learn, and adapt within a dynamic healthcare landscape, you will fit right into our core values: Put Others First, Have the Courage to Take Action, Take Personal Responsibility, and Have Fun! This position requires expertise in cleaning validation and monitoring in a cGMP facility. Key requirements include: Hands-on experience with CIP/SIP systems, washers, vessels, tanks, and manual cleaning. Development and execution of cleaning validation protocols and reports. Troubleshooting and optimizing CIP/COP systems, with experience in cycle development preferred. Data analysis and presentation of results, ensuring adherence to project specifications and timelines. Generation and resolution of protocol discrepancies. Review of GxP deliverables (specifications, procedures, validation documents). Training of operations staff on relevant protocols and procedures. Organization and tracking of validation activities to meet client timelines. Experience with various sampling techniques. Strong knowledge of cGMP requirements and excellent communication skills. Preferred skills: experimental design, problem-solving, organizational abilities, project management, discrepancy reporting, and root cause analysis experience. Requirements ● Requirements: Engineering Degree Knowledge of FDA and cGMP regulations Able to review and interpret data for scientific conclusions Strong written, verbal, and technical writing skills Proficient in Microsoft Office; quick to learn new applications Hands-on experience with validation in a cGMP environment Excellent problem-solving and decision-making abilities Capable of extracting information from technical documents Proactive in project management and contingency planning Skilled in workload management and prioritization Able to work independently and multitask to meet deadlines Team player with the ability to collaborate effectively Salary Range: 90k-100k Benefits Health Care Plan (Medical, Dental & Vision) Retirement Plan (401k) Life Insurance (Basic, Voluntary & AD&D) Paid Time Off (Vacation, Sick & Public Holidays) Azzur Group is an equal opportunity employer and promotes a diverse culture in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.