Quality Assurance Technician Jobs in Fitchburg, MA

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  • Auditor, GCP/GLP/Quality Assurance

    Fusion Pharmaceuticals

    Quality Assurance Technician Job 44 miles from Fitchburg

    Fusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs) as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors. Fusion's clinical portfolio includes: FPI-2265 targeting prostate specific membrane antigen (PSMA) for metastatic castration resistant prostate cancer currently in a Phase 2 trial; FPI-1434 targeting insulin-like growth factor 1 receptor currently in a Phase 1 trial; FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1), currently in a Phase 1 trial; and FPI-2068, a bispecific IgG-based EGFR-cMET targeted radioconjugate currently in a Phase 1 trial. In addition, Fusion is pursuing combination programs between RCs and DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. Fusion has a fully operational Good Manufacturing Practice (GMP) compliant state-of-the-art radiopharmaceutical manufacturing facility to meet supply demand for Fusion's growing pipeline of RCs. Position Summary Fusion has opened a newly created role in Quality Assurance for an Auditor, GCP/GLP/ Quality Assurance. This position will focus on GCP and GLP compliance within Fusion sponsored clinical trials and the R & D organization and provide clinical study oversight in preparation for commercialization. This position must have at least 1 year of GCP auditing experience for clinical sites and vendors. They will also have experience with participating with clinical study team s in the execution of study protocols. This role will report to the Sr Director of Clinical Quality Assurance. Responsibilities • Represent the GCP/GLP/PV Quality function on various clinical project teams and other working groups, functional areas, and with external partners providing GCP/GLP/PV oversight and supporting R&D clinical development programs through post marketing. • Ensures, where appropriate, that all personnel training, investigation, deviation actions, critical documentation and audit actions are completed and compliant for GLP and GCP studies • Executes against approved GLP and GCP audit plans and other GLP/GCP-related documents. • Participate and lead internal and external audits to assess compliance with GCP & GLP requirements, investigational plans, and Fusion standards for clinical trial related activities. • Provide consultation to Clinical Operations and Quality Assurance regarding GCP & GLP quality practices and issues. • Reviews GLP and GCP protocols, GLP and GCP study reports, and Standard Operating Procedures to ensure GLP and GCP compliance. • Assists the Nonclinical team with GLP compliance for animal rule and non-animal rule therapeutics and the Clinical team with GCP compliance for clinical studies. • Ensures required Quality Assurance expertise is available and effective for GLP and GCP study execution. • Support deployment and implementation of HIPPA, Data Integrity and GxP's • Ensuring regulatory commitments are met on time and sustainability measures are in place. • Ensuring where appropriate that all personnel training, investigation, deviation actions, critical documentation and audit actions are completed on time. • Ensuring escalation to the Sr Director of Clinical Quality Assurance and leadership of all critical concerns from the site related to clinical quality issues encountered at the CRO and partner's quality system. Qualifications • Bachelors Degree or equivalent is required, advanced degrees a plus • Certification in GCP Quality Auditing, a plus • Minimum of 5 years of work experience in the pharmaceutical industry and at least 1-2 years performing Clinical Quality Assurance functions (GCP) for clinical trials phases I-IV including the auditing of clinical investigators and CROs/vendors. • Knowledge of GxP/PV quality systems, quality assurance, quality control, and GCP/GLP/PV audits. • Experience supporting IT systems audits and understanding of GCP and GLP quality standards and practice is highly desired. • High level of written and oral communication skills and presentation skills. • Use of Microsoft Office (Excel, Word, Microsoft Project, PowerPoint). • Strong interpersonal and communication skills • Strong written and verbal communication skills • Effective/concise communicator with management and internal teams • Experience with working in start-up environments moving in rapid growth/manufacturing • Influences a strong quality and compliance culture internally and externally All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual, gender identity, national origin, disability, or status as a protected veteran.
    $72k-117k yearly est. 16d ago
  • Manufacturing Technology SME

    PM Group 2.8company rating

    Quality Assurance Technician Job 35 miles from Fitchburg

    PM Group is currently engaged in the delivery of multiple Life Science projects in the USA. Together we will all be sharing knowledge, learning, growing and continuing to be an integral part of supporting PM Group's ongoing expansion in the US. Outsourced Technical Services (OTS) is an integral part of our ability to support clients across the complete project life cycle. We deliver fast, flexible outsourcing solutions for clients worldwide. You will be on-site executing cutting-edge projects for Cell & Gene Therapy, Biologics, and Pharma facilities for both US and international clients. PM Group is an employee owned, international project delivery firm with a team of 3,600+ people. We are world leaders in the pharma, food, biotech, medical technology and mission critical sectors. From our network of offices in Europe, Asia and the US, we work with the world's leading organizations. We are focused on growing a sustainable business centered on our people, our clients and trade partners. Responsibilities Cross functional Team Leadership: Lead within cross functional teams to achieve facility start up and technology transfers. The Manufacturing Technology SME in the cross-functional team plays a critical role in ensuring that the facility fit, and technical transfer is successful, compliant, and efficient, while maintaining a strong focus on collaboration, communication, and quality. Technical SME: The role is responsible to represent the Engineering & Technology as facility fit and technical SME. Ensure appropriate equipment specification and procurement through qualification with the QAV SME. Raw material quality for use in manufacturing working in collaboration with PD and QC SME. Interact with process development teams on process design finalization (and control strategy as applicable) in terms of facility/equipment specifics, manufacturability, capacity and cost analysis, process controllability and robustness. Coordination and Communication: Facilitate effective communication and collaboration between different teams, departments, and stakeholders involved in the technical transfer process. Project Planning: Work with a project manager to develop a detailed project plan outlining timelines, tasks, resources, and milestones. This plan should consider potential risks, contingencies, and strategies to address any challenges that may arise during the transfer. Risk Management: Identify potential risks and challenges associated with the technical transfer process, and work with the team to develop mitigation strategies to minimize these risks. This could involve quality issues, regulatory compliance, equipment compatibility, operability, cost considerations and more. Regulatory Compliance: Ensure that all activities related to the technical transfer comply with relevant regulatory guidelines and standards. Quality Assurance: Collaborate with quality assurance and control teams to ensure that the transferred process or product maintains its quality, safety, and efficacy throughout the transfer process. Documentation: Ensure accurate and comprehensive documentation of all steps in the transfer process. This documentation is crucial for regulatory submissions, troubleshooting, and future improvements. Resource Allocation: Work with the project manager to ensure the necessary resources are allocated, such as personnel, equipment, and materials, to support the successful execution of the technical transfer. Problem Solving: Work proactively to address any issues or roadblocks that arise during the transfer process, working with the cross-functional team to find effective solutions. Execute technical assessments of new equipment, instruments, and single-use technology to identify optimal solutions in a fast-paced environment. Training and Knowledge Transfer: Facilitate the training of personnel involved in the technical transfer, ensuring that the receiving team has the necessary skills and knowledge to continue the process smoothly. Continuous Improvement: Identify real time opportunities for process optimization and improvement during the transfer, with the goal of enhancing efficiency, reducing costs, and maintaining or improving product quality. Conduct risk assessments/FMEA Be able to problem solve using systematic approach to root cause analysis. Owner and author of relevant documents which represent the process for GMP manufacturing including, but not limited to SOPs, process descriptions, master batch records, compounding records, critical raw material lists, bill of materials, part number and specification generation, sample map. Owner and author of process related change controls, deviations and CAPA to ensure events have no impact to process performance and product quality, and recurrence is eliminated. Assess and approve non-process related change controls, deviations and CAPA to ensure events have no impact to delivery of acceptable quality product and recurrence of issues are eliminated. Perform other responsibilities as required. Qualifications Minimum Bachelor of Science degree in Biotechnology area, Biological Sciences, or Chemical Engineering. 7+ years' experience with biotech process development, process scale up, tech transfer or manufacturing in the biopharma/biotech industry. 3+ years' experience with functional or cross functional team leadership Demonstrated expertise with multiple tech transfer and scale up of biologic molecules for GMP clinical or commercial production, specifically in advanced therapies manufacturing example viral vector, RNA, cell processing. Prior direct experience in either design, qualification, start-up, or initial licensure of Biologics Manufacturing facilities preferred. Demonstrated evidence of detailed direct experience with process, equipment, single use technology, automation, validation, and facility fit knowledge. Thorough understanding and demonstrated experience with FMEA, risk analysis, process characterization or process validation. Knowledge of quality systems, cGMP, regulatory and industry standards at all phases of drug development. Understanding of regulations pertaining to cGMP manufacturing and analytical requirements for Raw Materials, Critical Components, Drug Substance and Drug Product and the translation of those regulations into process development work products and GMP manufacturing process design. Experience with statistics in the areas of statistical process control, modeling, and data management. Computer skills (MS Office Suite, statistical software, Visio, LIMS, SAP, etc or equivalent). Ability to solve complex problems, and a proactive preventative mindset to enable flawless manufacturing. Strong interpersonal and communication skills - able to clearly express ideas and point of view both verbally and in writing Show commitment and dedication and strive to be ahead of schedule. Maintain on the floor presence to support oversight of operations in conjunction with Manufacturing Leadership - amount of time on the floor will be relative to the development of manufacturing associates as the organization is established. Practice safety awareness always and consider safety when establishing MBR and implementing changes for manufacturing. Share 24/7 on-call support while the product is being manufactured. Why PM Group? As an employee-owned company, we are inclusive, committed and driven. Corporate Responsibility and Sustainability are the heart of our new 2025 business strategy. Click here to read more in our Corporate Responsibility and Heath, Safety & Well-being Report 2023. Inclusion and Diversity are core to our culture and values. Wherever we work, we commit to a culture of mutual respect and belonging by building a truly inclusive workplace rich in diverse people, talents and ideas. Valuing the contributions of all our people and respecting individual differences will sustain our growth into the future. PM Group is committed to ensuring our hiring process is fair and accessible to all and will provide candidates with disabilities with reasonable accommodations required to participate in the recruitment process. If you require any assistance in this regard, please let us know. RECRUITMENT AGENCIES NEED NOT APPLY
    $36k-43k yearly est. 23d ago
  • Quality Assurance Validation Specialist

    Insight Global

    Quality Assurance Technician Job 44 miles from Fitchburg

    The Engineer is actively involved in Commissioning, Qualification, Validation, and Requalification activities for Cell and Gene Therapy facilities. The individual is responsible for executing qualification protocols at the client's facilities and collaborate with Global Engineering, Facilities Operations, GIS, QA and PMO throughout the life cycle of the project. This position reports directly to the Manager of Validation. Key Responsibilities: The responsibilities of this position may include, but are not limited to, the following: Develops and executes qualification and validation test plans and protocols. Ensures that all validation documents align with the current SOPs, global standards and cGMP guidelines. Coordinates with personnel onsite and other vendors to schedule and execute test plans. If required, coordinates with the construction team and operations teams to schedule execution of validation activities, safely and effectively. Effectively works with cross functional departmental stakeholders, PMO, GIS, EH&S, Global Security, design teams, EHS and QA. Supports right-the-first time culture for all documents distributed across the organization. Ensures the Global Engineering reputation and partnership is flourished with the cross-functional teams. Minimum qualifications: Receptive to change - Adapts (quickly) to changing circumstances. Minimum Bachelor's degree in an Engineering (Chemical, Biomedical, Industrial, Biotechnology) or related discipline with 2-4 years of CQV experience or equivalent professional experience. Self-motivated and must be able to work independently with minimal supervision and direction. Experience in developing and executing protocols in GMP industry. Experience using Kaye Validator and Data loggers. Understanding and application of technical principles, theories, and concepts in the field, GMP, ISO, GAMP, ANSI. Ability to learn and demonstrate technical problem solving and troubleshooting skills. *Pay Range is $40-55/hr Depending on Years of experience, education, and other factors*
    $40-55 hourly 8d ago
  • Food Safety and QA Specialist

    Cooke Inc.

    Quality Assurance Technician Job 31 miles from Fitchburg

    Reporting to the Vice President of Food Safety & Quality Assurance for our subsidiary, Slade Gorton, the Regulatory and QA Specialist is responsible for ensuring all elements of product labeling are accurate and comply with applicable government regulations, and all product specifications and related data and documents are maintained up-to-date in our systems and on customers' platforms. In addition to being the subject matter expert in regulatory affairs, the ideal candidate must have a strong aptitude for technology, a keen eye for detail and accuracy, efficient workflow management skills and a collaborative and professional demeanor. To excel in this role, problem-solving skills and the ability to work collaboratively with both internal and external partners (suppliers and customers) are essential. This role will also act as a back-up for QA Manager in product inspection and supplier documentation management. Objectives Continuously strive for the improvement of Company product specifications, regulatory compliance, data and data systems and processes in support of the Company's strategic imperatives of creating a world class supply chain. Proactively collaborate as a solution-focused subject matter expert for the cross-functional team to ensure that products and projects are regulatory compliant, competitively positioned, and that information and data sharing is accurate and timely. Ensure customers' documentation needs are completed timely and regularly. Cross-trained as a back-up for QA Manager in product inspection and supplier documentation management. Key Responsibilities Manage all incoming supplier product information, create and maintain up-to-date specifications that are aligned with customers' expectations, approve item setup requests, and accurately disseminate data to downstream systems (ERP, GDSN, customer specification platform, etc.) Evaluate product specifications, formulations, ingredient statements, nutritional facts tables, labeling and claims, artworks, and promotional materials for new and existing products against the appropriate regulations, guidelines, and internal labeling standards. Resolve any specification differences with stakeholders. (Suppliers, Procurement, Sales, Marketing) Maintain customer platforms to ensure required supplier and product documents are kept current. Remain current on all applicable regulations and ensure regulatory changes are communicated to the key stakeholders and implemented timely. Provide support and guidance on regulatory topics as needed. Implement processes, procedures, and workflow for effective product creation and maintenance in GDSN and customer's portals. Work with Sales to ensure marketing materials and product photos are kept current Work collaboratively with key customers to ensure adherence to their evolving data requirements and help communicate their needs to various business leaders within the Company. Cross-trained in seafood product inspection and documentation management, and be back-up to the QA Manager. Other duties as directed Key Skills needed for success Demonstrated solid knowledge of regulatory (theory and practice) along with good understanding of food supply chain and manufacturing processes An analytical mindset with the ability to effectively decipher and organize large amounts of data.Ability to communicate complex issues clearly and in nontechnical terms Strong organizational skills that reflect ability to perform and prioritize multiple tasks seamlessly with problem-solving, critical thinking capabilities, and attention to details Excellent interpersonal skills to effectively and proactively work across functions and enable the development of relationships with key stakeholders Highly resourceful team-player, with the ability to be effective independently and seek assistance and direction periodically on complex issues Self-starter, drive for results with strong work ethic and integrity Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment A forward thinker, who actively seeks opportunities and proposes solutions Education and Experience Requirements Bachelor's degree in food science, nutrition, or related field A minimum of 3+ years direct experience in regulatory affairs with excellent knowledge in US food labeling regulations Food manufacturing and/or supply chain experience is a must Highly proficient in Microsoft Office (Excel, Outlook, Word, and Power Point) Experiences with GDSN, Nutritional Calculator (e.g. Genesis), TraceGains, PLM, PIM, are preferred Ability to handle raw seafood in refrigerated environment Some travel may be required
    $63k-93k yearly est. 23d ago
  • QA Associate I, Hollowfiber

    Repligen Corporation

    Quality Assurance Technician Job 21 miles from Fitchburg

    Repligen is an innovative life sciences company focused on developing and commercializing high-value bioprocessing products, technologies, and solutions critical in the production of biologic drugs. We are currently seeking a QA Associate I to join our Quality team in Marlborough, supporting Hollow Fiber and Single Use ATF Manufacturing. The QA Associate I will actively participate in the Repligen ISO 9001 Quality Management System, reviewing production records and releasing product, as well as supporting other QA team members and areas of work, as needed. The successful candidate will have a positive attitude and be able to communicate effectively. This candidate will be responsible for assisting the QA department to revise/create, file, organize, and review production documents. The candidate will work closely with the manufacturing teams to ensure accuracy of production documentation throughout the production process. This position involves completing the QA review of production records, including but not limited to; verification of raw materials used, verification of calculations, good documentation practices, and processing steps have been completed according to the internal processes. Responsibilities Review production records for compliance to ISO standards and internal processes. Process SAP transactions to accept and release batches. Review/approve the root cause, investigations and dispositions of non-conformances, deviations and other quality related events. Create/revise documents, spreadsheets and presentations using Microsoft Office. Participate in daily/weekly/monthly meetings. Qualifications Requirements: A BA/BS degree (in a Biological Science, Engineering, or Physical Science) is preferred but not mandatory. Minimum 0-2 years' experience in Quality Assurance in an ISO 9001 certified Quality Management System or equivalent. Ability to identify and ensure active and thorough investigations of quality issues identifying root causes and implementing corrective actions. Identifies and controls manufacturing process defects (scrap, nonconforming material, customer complaints) is highly preferred. What Repligen Offers Excellent Benefits! Health Insurance available on day one 4 Competitive Medical Plan Options Dental, Vision, Life and Disability Insurance Plans 401K Health Care Savings Account Well Being Programs 20 Days of PTO Tuition Reimbursement Program
    $51k-74k yearly est. 29d ago
  • Quality Assurance Specialist

    Biotalent

    Quality Assurance Technician Job 35 miles from Fitchburg

    This role will work with a high degree of independence to support the Quality Assurance organization by working on Corrective and Preventive Actions (CAPAs) by assisting with Root Cause Analysis (RCA), following up on open actions, and assuring timeliness of action completion, and effectiveness checks, This role will also coordinate quality events with subsidiaries, training, conduct audits, and other critical QA function as described below. Responsibilities: GxP knowledge with global understanding/application of phase appropriate regulations. Oversee CAPA database and assure prompt completion of activities. Assist in investigations related to complaints, process, or material investigations. Gain oversight of electronic Quality Management System (eQMS) and assures company compliance to procedures. Responsible for timely completion and recording of trainings, conduct company training as needed. Ideal Background: Display leadership skills including proven record of being a results driver and being able to collaborate in a cross-functional environment. Proven track record managing CAPA processes and facilitating change through process improvements. Working knowledge in the principles and the application of quality assurance and compliance within a medical device environment. Experience working with Contract Manufacturing Organizations (CMOs) is a plus. Experience working with sterile product is preferred.
    $63k-94k yearly est. 10d ago
  • Quality Control Technician

    Randstad 4.6company rating

    Quality Assurance Technician Job 37 miles from Fitchburg

    Our client, a leading manufacturer of paper products, is seeking a Quality Control Technician to join their team in North Andover, MA. This direct hire position offers competitive pay and benefits. In this role, you will become an expert in the operation of production machines, perform daily Quality Control functions, and develop Manufacturing Technician skills to support R&D, Production and Engineering. The ideal candidate will have a 2- or 4-year degree in Engineering (or equivalent experience), the ability to work hands-on in a fast-paced environment, organizational skills, and a keen attention to detail. If you're a self-starter looking for a dynamic opportunity, apply today! Location: NORTH ANDOVER, Massachusetts Job type: Permanent Salary: $52,000 - 64,480 per year Work hours: 8am to 4pm Education: High School Responsibilities: Learn and assist with production equipment and troubleshooting. Test products during production to Quality Test Procedures and document results. Collaborate with operators to ensure quality production. Analyze production data and maintain product specifications. Update Quality Control Test Procedures and Manufacturing Process Sheets. Minimize waste and improve productivity and quality. Investigate claims, non-conforming products, and process issues; issue Corrective Actions. Work with supply vendors on production/quality needs. Ensure quality products are produced in collaboration with management. Assist with product development and scale-up for manufacturing release. Review Safety Procedures and participate in safety meetings. Maintain Safety Training Records. Qualifications: Experience level: Experienced Minimum 2 years of experience Education: High School (required) Skills: Quality Troubleshooting MS Office #quality #qualityengineering #engineering #qualitytechnician #Troubleshooting
    $52k-64.5k yearly 9d ago
  • Quality Supervisor

    Circor International, Inc. 4.4company rating

    Quality Assurance Technician Job 33 miles from Fitchburg

    CIRCOR Naval Solutions - Warren, MA Reports to: Quality Engineer, Supervisor Functional Reporting: Quality Manager CIRCOR Naval Solutions is seeking a highly motivated Quality Supervisor to oversee the daily operations of the inspection and quality technician team in a manufacturing environment. This role plays a critical part in ensuring production efficiency, maintaining product quality, and meeting production schedules. The ideal candidate will be responsible for managing priorities, setting team goals, and providing key metrics to support operational success. Additionally, this position involves training and cross-training employees in inspection processes while ensuring compliance with customer contracts, regulations, and industry requirements. Key Responsibilities Team Leadership & Operations Management: Supervise daily activities of quality inspectors and technicians. Prioritize and assign work based on production schedules and business needs. Manage employee work hours, schedule overtime as required, and ensure workforce efficiency. Set team goals and oversee performance management. Quality Assurance & Compliance: Interpret and apply ASTM, Military, DFARS, and FAR specifications and drawings to ensure compliance. Develop, implement, and enhance quality plans, including FAIRs, FAT/IAT, inspection steps, tools, and sampling plans. Perform material certification reviews to confirm supplied products meet contractual and specification requirements. Inspect products to verify compliance with contracts and engineering drawings. Lead the Material Review Board (MRB) and Supplier Issue Resolution (SIR) processes in collaboration with the Quality Manager. Address and resolve customer escapes and corrective action requests (CARs), including preparing reports like VIRS, VPARS, LOAs, and RCCA responses. Collaboration & Support: Partner with manufacturing teams to ensure product quality is maintained throughout production. Mentor and provide guidance to inspectors, ensuring employees are qualified for their roles (e.g., NDT, Weld, RT sign-offs). Support government and customer source inspections as required. Maintain a safe, organized work area, ensuring equipment and supplies meet quality and safety standards. Qualifications & Requirements Education & Experience Bachelor's Degree in Mechanical, Manufacturing Engineering, or a related technical field required. 5+ years of experience in quality engineering within a manufacturing environment. Strong background in auditing, quality principles, and process improvement methodologies. Technical Skills & Certifications ASQ Quality Engineer Certification (preferred). Strong knowledge of machining, blueprint interpretation, ANSI Y14.5 GD&T. Experience with Six Sigma (Green Belt/Black Belt preferred). Familiarity with industry standards: AS9100, ISO 9001, ISO 14001. Knowledge of NDT (RT, PT, VT) and AWS welding requirements is a plus. Proficiency in Microsoft 365 (Word, Excel, PowerPoint, Power BI, SharePoint, TEAMS). Additional Requirements Prior experience in the Defense Industry and working with DOD contractors is a plus. Must be a U.S. Citizen (required for defense contracts). Ability to obtain a DOD security clearance. Strong leadership and problem-solving skills, with the ability to manage multiple priorities in a fast-paced environment. About CIRCOR Naval Solutions CIRCOR International (*************** is a global leader in mission-critical flow control products and services, serving the Industrial and Aerospace & Defense markets. CIRCOR's Naval Solutions division, rooted in Warren Pumps since 1897, specializes in custom-built, highly engineered pumps for the U.S. Navy's submarine and surface ship programs. With expertise in exotic materials and both centrifugal and positive displacement technologies, we continue to deliver innovative solutions for demanding defense applications. CIRCOR is an Equal Opportunity Employer committed to diversity, inclusion, and supporting Veterans, Individuals with Disabilities, Women, and Minorities in the workforce.
    $49k-72k yearly est. 21d ago
  • CMC QA Asssociate

    Tandym Group

    Quality Assurance Technician Job 27 miles from Fitchburg

    A pharmaceutical company in Massachusetts is currently seeking an experienced professional to join their staff as their new CMC QA Associate. Reporting to the Senior Director of CMC QA, the CMC QA Associate will be responsible for supporting the cross functional team (i.e. PD, MSAT, CMC, Manufacturing, Regulatory Affairs etc.) to confirm the appropriate quality as well as compliant controls are in place for assigned Gene Therapy programs, and working with colleagues to improve processes utilized to ensure product quality. This is a hybrid role in Bedford, Mass. Responsibilities: Provide quality oversight and support to ensure clinical through commercial development lifecycle activities for drug substance and drug product meet cGMP regulatory requirements and guidelines at GTMF and/or contract manufacturing organizations (CMO) Support review and approval of process characterization studies and associated report Provide quality oversight of process performance qualifications and associated studies Review and approve process validation protocols and reports (i.e., Mixing validation, hold studies, extractable and leachable, impurity, column storage etc.) Review and approve tech transfer plan, report, and associated deliverables Author and review of regulatory submissions and responses Review and approve batch records, CC, deviations, and other quality systems Support batch disposition and release Perform other duties, as needed Qualifications: 7+ years of experience in a GMP Biopharmaceutical Manufacturing environment in Technical Operations and/or Quality Bachelor's Degree Strong working knowledge and interpretation of FDA, EMA, local regulations and guidelines, Good Distribution Practices, ICH guidelines and industry best practice Experience supporting authoring/ reviewing/ approving technical studies Experience leading and participating in investigations into manufacturing and analytical deviations and determination of product impact, root cause, and corrective and preventative actions Experience with performing technical assessment of changes for potential impact to qualification/ validation of processes, equipment, utilities, facilities and systems Experience in all phases of biologics, gene therapy, and/ or cell therapy drug development Expert knowledge of cGMP compliance regulations and industry practices for US/Ex-US Desired Skills: Bachelor's Degree in Biotechnology, Biological / Physical Sciences, and/or Engineering
    $51k-74k yearly est. 10d ago
  • Quality Control Specialist

    Masis Professional Group

    Quality Assurance Technician Job 34 miles from Fitchburg

    Growing Radiopharmaceutical Contract Manufacturing (CMO) site has a new direct hire opportunity for a Quality Control Specialist to join their team! The CMO site manufactures and provides radiopharmaceuticals, medical isotopes, and related services, particularly for cancer treatment and research. They offer a very generous compensation & benefits package as well as a very pleasant work culture! Job Summary: The Quality Control Specialist will assist the Quality Control Manager in maintaining an effective quality control program which consistently strives to test and release high quality products on time. This person will participate in quality tests and inspections to verify that appropriate current procedures are followed and will keep the QC Manager fully informed on the status of QC activities. Responsibilities: Operates under the guidance of the QC Manager to assure compliance with the company's quality control program as well as the quality management system (QMS) Communicates with the QC Manager on activities related to quality control Performs final quality control testing on products as assigned by the QC Manager Performs periodic calibration and qualification of analytical equipment, which include: Pipettes Analytical balances Incubators and ovens Freezers and refrigerators Gamma and alpha spectrometers Liquid scintillation counters HPLC Systems Assists in analytical methods development and validation activities Performs incoming materials inspection and carries out quantitative and qualitative tests to qualify them as per approved protocols Maintains inventory and usage log for raw materials Assists in deviations, root cause analyses, corrective/preventive actions and non-conformity reports Carries out filing, organizing and record keeping of QC documentation Recommends continual improvement changes to QC procedures and processes where necessary. Performs other duties as assigned by QC manager Requirements: Bachelor of Science (B.S.) degree in relevant discipline (Chemistry, Pharmacy, Nuclear Chemistry, Biochemistry etc.) Minimum 2 - 3 years' experience with pharmaceutical Quality Control, preferably radiopharmaceutical. Proficient in the operation, calibration and routine maintenance of general analytical equipment, such as balances, pipettes, HPLC systems etc. Proficient in the review, revision and authoring of official documents such as standard operating procedures, work instructions etc. Proficient in Microsoft Excel and Word Able to lift up to 50 lbs. Desirable Traits: Experience of working with measuring equipment pertaining to radioactivity (gamma spectrometers, alpha spectrometers, liquid scintillation analyzers, gamma counters, dose calibrators etc.) is highly desirable Experience of working with HPLC, GC, ICP/OES is highly desirable Experience working with electronic document management systems / LIMS Experience in statistical analysis and trending of QC-relevant data Knowledge of the conceptual and practical application of cGMP in a pharmaceutical environment Able to work in a fast-paced environment and meet quality, accuracy and timeliness objectives Hands-on, having a knack of working with tools and fixing minor equipment maintenance issues Detail-oriented and organized with excellent written and verbal skills Able to work independently as well as in a team Is flexible to work odd hours and occasionally on weekends/holidays, as needed.
    $46k-77k yearly est. 12d ago
  • Travel Cath Lab Technologist - $2,637 per week

    Healthtrust Workforce Solutions HCA

    Quality Assurance Technician Job 34 miles from Fitchburg

    HealthTrust Workforce Solutions HCA is seeking a travel Cath Lab Technologist for a travel job in Derry, New Hampshire. Job Description & Requirements Specialty: Cath Lab Technologist Discipline: Allied Health Professional Duration: 13 weeks 36 hours per week Shift: 10 hours, days Employment Type: Travel Entrust Your Career to HealthTrust! At HealthTrust, we believe that healthcare is not defined by the four walls in which it is practiced; it's defined by its people. We pride ourselves on crafting opportunities that expand skill sets, broaden career horizons, provide economic stability, and cultivate personal growth. HealthTrust Offers: • Competitive Pay Packages • Guaranteed hours • Weekly direct deposit options • 401k with Company Match • Earn up to $750 for referrals • Free Private Furnished Housing or Tax-Free Subsidy To get started, you will need: • An adventurous spirit and fierce dedication • A degree from an accredited school of nursing • Minimum 1-year acute care experience in a hospital setting • Current State Nursing License • Appropriate certifications for the specific position HealthTrust Benefits: · Opportunities for a lifetime: When you become a part of the HCA family, you will have exclusive access to more opportunities than any other healthcare system in the nation. At HWS, we help open the door to a lifetime of lasting career opportunities. · A culture of care: Our clinicians have made HWS an industry leader for over 25 years. We are passionate about our mission that, above all else, we are committed to the care and improvement of human life. · Career Development: As a wholly owned subsidiary of HCA Healthcare, HWS is a preferred partner to thousands of top-performing hospitals. We provide our healthcare professionals with first-priority access to more than 200,000 jobs nationwide. We are uniquely positioned to offer you exclusive and direct access to HCA Healthcare's vast network of facilities. Let us open the door to nationwide opportunities that fit your lifestyle! We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. Candidate Requirements State license requirements: New Hampshire Preferred clinical experience: 1 year minimum experience Interview requirement: Phone interview HealthTrust Workforce Solutions HCA Job ID #879131. Posted job title: Travel Cath Lab Tech - General - Cath Lab Tech About HealthTrust Workforce Solutions HCA At HealthTrust Workforce Solutions, healthcare is not just about the four walls of a facility but about the people who provide and receive care. Our focus is on empowering healthcare professionals to deliver exceptional patient experiences by providing them with the necessary skills, tools, and support. We partner with healthcare facilities nationwide to ensure that the right professionals are in the right roles. We prioritize our clinicians by giving them a voice and access to opportunities to fulfill their mission of improving lives by providing quality patient care. We are committed to our core values of Trust, Innovation, Adaptability, Courage, and Accountability. We are dedicated to positively impacting the healthcare industry by providing first-priority access to more than 200,000 jobs nationwide to our healthcare professionals. Join us and be part of the HealthTrust family, where you can make a difference every day. We embrace our changing environment, and we maintain a culture that has a rich tradition of transforming itself to meet the challenges of the future. MISSION STATEMENT While putting great people in the right roles is essential, our mission is far greater. We want our clinicians to be part of the HealthTrust family, where healthcare professionals have a voice and are empowered with the right tools and opportunities to fulfill their personal mission of improving lives. Plus, as a preferred partner to thousands of top-performing hospitals, we provide our healthcare professionals with first-priority access to more than 200,000 jobs nationwide. Benefits Dental benefits Vision benefits Referral bonus Continuing Education Life insurance
    $31k-44k yearly est. 2d ago
  • Quality Technician 2nd Shift

    Oatey 4.3company rating

    Quality Assurance Technician Job 34 miles from Fitchburg

    75 Plumb Pak Drive, Winchester, New Hampshire 03470 United States of America * Who is Oatey? Since 1916, Oatey has provided reliable, high-quality products for the residential and commercial plumbing industries. Our purpose is to deliver quality, build trust and improve lives. The Oatey family of companies are Oatey, Cherne, Keeney, Quick Drain, Hercules, Dearborn, GF Thompson, William H. Harvey, Masters, Contact, Belanger, and Lansas. Our brands are synonymous with quality, integrity, and trust in the plumbing industry. * Position Summary Ensures the quality of all processes, procedures, materials, processes rework and finished products. Also performs scheduled tasks as support for environmental and safety functions with additional responsibilities as assigned. Position Responsibilities Conduct daily quality inspections in all departments to audit the following: Procedure compliance/documentation with ISO9001 quality systems. In-process quality inspections, using established procedures. Incoming inspection, including first piece inspection, verification of Supplier's Certificates of Analysis, etc. Validation of product quality conformance to specifications. Complete ongoing Reliability Testing to ensure current products continue to meet product performance and/or formulation specs. Provide disposition and segregation of rejected materials and/or products. Summarize data and provide appropriate reports. Maintains rework inventory. Provides samples and sample data. Maintain calibration/verification records for all lab testing instrumentation and hand-held devices. Prepare test pipes (go-no go Gauges) for fit testing. Supply manufacturing with calibrated measuring and test equipment. Provide organizational quality support by assisting with problem resolution on the shop floor which includes gathering information on any quality-related issues, conducting root cause analysis and providing resolution for non-conformities. Participate in manufacturing CIP meetings as the QA representative and in ongoing quality training of manufacturing and QA staff. Maintain good housekeeping in lab, office and storage areas. Maintain and keep organized all QA files and documentation for easy reference and ISO9001 documentation compliance. Other duties as assigned. Knowledge and Experience Good communication and organizational skills. Computer literacy with Microsoft Office software applications. Excellent problem-solving and analytical skills. Basic understanding of quality concepts including variation, process control and root cause analysis. Cooperative attitude toward co-workers and supervisors. Knowledge of various equipment used in a laboratory (Fill machines, pallet jack, box knife, batch gun, mix tanks, drum mover, microscope, viscometer, Gas Chromatograph, and computer). Education and Certification High School Diploma required. Associate's Degree in a business, engineering or scientific course of study or equivalent experience in a manufacturing or laboratory environment preferred. * Why Oatey? * At Oatey, our purpose has always been to deliver quality, build trust and improve lives. * We value Collaboration, Integrity, Respect, Courage, Leadership, and Excellence above all else. * We embrace diversity, equity, and inclusion - acknowledging, valuing, and leveraging the unique experiences and perspectives of our associates. * Our vision is to continue to grow as a market leader, to enrich the lives of our Associates, and to foster an inclusive environment in every regard. * Our purpose, mission, and vision are not possible without the right people, and we are committed to fostering an inclusive, engaging, and rewarding environment for our Associates. * Oatey has a total rewards philosophy which encompasses compensation, benefits, work-life effectiveness, recognition, performance management, tuition reimbursement, mental health wellness, and talent development.
    $39k-48k yearly est. 44d ago
  • Quality Technician

    Leonardo DRS, Inc.

    Quality Assurance Technician Job In Fitchburg, MA

    **Job ID: 111686** The Leonardo DRS Naval Power Systems business is a trusted provider of innovative naval gas and hybrid power systems, control technology and support solutions for the U.S. Navy and navies around the world. The Quality Technician ensures process compliance, performs in-process and final inspections, and supports continuous improvement initiatives within a complex build-to-print manufacturing environment. This role is critical in maintaining high-quality standards and ensuring adherence to industry specifications and customer requirements. **Job Responsibilities** + Perform in-process and final inspections on mechanical, electrical, and optical assemblies to ensure conformance to engineering drawings, specifications, and industry standards. + Conduct process compliance surveillance to ensure adherence to documented procedures, work instructions, and best practices. + Quickly identify and communicate process deviations and non-conformances, working with production and engineering teams to implement corrective actions. + Interpret and apply GD&T (Geometric Dimensioning and Tolerancing) requirements on assembly drawings. + Utilize precision measuring instruments such as calipers, micrometers and height gauges. + Review and verify documentation for accuracy, completeness, and compliance with customer and regulatory requirements. + Assist Quality Engineers in developing inspection plans, conducting MRB (Material Review Board) investigations, and executing process surveillance activities. + Support calibration activities, ensuring equipment and tooling meet required specifications. + Work from complex wiring diagrams, operation sheets, engineering specifications, and sketches. + Provide guidance to production teams regarding quality control processes and best practices. + Maintain compliance with safety regulations, company policies, and industry certifications. + Assist in training new team members on quality inspection procedures and process adherence. + Adherence to production schedules while maintaining quality standards. + Pass/fail rates of inspected products. + Reduction of process non-conformances through proactive process surveillance, product inspection and reporting. + Compliance with industry standards such as IPC-610, ANSI J-STD-001, and other relevant specifications. + Effective coordination of multiple inspection activities in a dynamic production environment. **Qualifications** + Associate's degree in a technical discipline or equivalent experience in quality inspection or a related field. + Strong understanding of quality assurance principles, inspection techniques, and process compliance. + Experience working within a quality management system equivalent to ISO 9001 or AS9100, preferred. + Experience in handling delicate components with adherence to ESD (Electrostatic Discharge) best practices. + Proficiency in interpreting technical drawings, GD&T, and industry standards. + Knowledge of MRP systems and data analysis tools is a plus. + Proficiency in using various computer applications, including Access, Excel, and LabVIEW. + Strong decision-making skills with the ability to prioritize tasks in a fast-paced environment. + US Citizenship required. U.S. Citizenship required. _Taking care of our people is a top priority at Leonardo DRS. We are proud to offer competitive salaries and comprehensive benefits, including medical, dental, and vision coverage, a company contribution to a health savings account, telemedicine, life and disability insurance, legal insurance, and a 401(k) savings plan. We champion wellness programs that focus on physical, emotional, and financial well-being. We develop our talent by offering programs and activities to support career-growth, professional development, and skill enhancement. And we understand there is more to life than work, and the importance of offering flexible work schedules with our 9/80 program, competitive vacation, health/emergency leave, paid parental leave, and community service hours._ _*Some employees are eligible for limited benefits only_ _Leonardo DRS, Inc. and its subsidiaries provide equal opportunities to all employees and applicants for employment and prohibit discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, protected veteran status, or any other characteristic protected by federal, state, or local laws._ _\#NPS #LI-LT1 #INDNPS_
    $32k-48k yearly est. 34d ago
  • Quality Technician - 3rd Shift

    Eptam Plastics

    Quality Assurance Technician Job 9 miles from Fitchburg

    EPTAM Precision Molding is looking for a Quality Technician - 3rd Shift to join our team in Lancaster, MA EPTAM Precision Molding is a trusted injection molding solutions partner. We are dedicated to supporting the complete product lifecycle in consumer products, healthcare, and defense industries. We're committed to helping our customers bring their products to market and streamline their supply chain. EPTAM Solutions, Our parent company, with locations nationwide, is at the Heart of Manufacturing. We recognize our parts touch lives, and our teams assume this responsibility with vigor. Our minds never sleep. Join our incredible team at any one of our locations and reap the benefits of an employee-focused company. We excel at what we do for our customers, our employees, and the world. POSITION SUMMARY: The Quality Technician performs complex First Part/First Article and WIP inspections of components in an injection molding manufacturing operation. ESSENTIAL FUNCTIONS: Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions Measures and documents dimensional characteristics utilizing analytical, technical and inspection methods. Controls inspection, measuring and test equipment under the metrology calibration system and determines the equipment is accurate and currently calibrated to established metrology standards, GMP (Good Manufacturing Practices) and company requirements. Perform inspection duties to insure that production product fulfills all customer specification and quality requirements Performs visual inspection of injection molded components and sub-assemblies, and systems or units to ensure that all product meets the established specifications for reliability and workmanship. Utilizes gages, templates, microscopes and other manufacturing aids to ensure that all product meets the established specifications for reliability and workmanship. Consistently works on quality dimensional assignments requiring independent action and a high degree of initiative to resolve issues. Capability of recommending type of measurement tools needed. Interface with tool vendor/supplier on any given basis. Analyze/Provide data of the outputs and create reports to assist in quality improvement activities. Lead inspection/containment activities related to dimensional issues working closely and leading Team Members Enters all quality data into the appropriate electronic or manual systems. Accurately completes all administrative activities associated with quality inspection. Ensures ISO and safety standards are adhered Understand and execute all plant policies and procedures. OTHER RESPONSIBILITIES: Ability to effectively present information and respond to questions from groups of managers, clients, customers. Ability to define problems, collect data, establish facts, and draw valid conclusions Ability to operate a personal computer including using a Windows based operating system and related software. Advanced PC skills, including training and knowledge of EPTAM's software packages (IQMS). MINIMUM JOB QUALIFICATIONS REQUIRED: EDUCATION : Associates degree or a combination of experience and education. EXPERIENCE: Training and experience equivalent to 4 years in a quality discipline in a manufacturing environment. ASQ (American Society for Quality) Quality Technician certification and/or ASQ Inspection certification are desirable. Working knowledge of reading & accurately interpreting engineering drawings, GD&T (Geometric Dimensioning and Tolerancing) and statistical analysis Able to use calibrated inspection equipment to validate dimensions or features 1+ years experience in an injection molding operation (preferred) Experience in a 24/7 manufacturing/molding operation (preferred) OTHER MINIMUM QUALIFICATIONS: Must possess good written and verbal communication skills with our internal and external customers. Basic knowledge of equipment. Advanced ability to read prints and use measuring equipment along with advanced math skills. Demonstrates experience in performance development, teaching/leading, mentoring and/or organization development. Instills appropriate behavior in others in support of EPTAM values ADP1253 ZZJ-250115-255
    $32k-48k yearly est. 4d ago
  • Quality Technician - Third Shift

    Garlock Flexibles

    Quality Assurance Technician Job 9 miles from Fitchburg

    The Quality Technician performs quality control tests/inspections on products at various stages of production process. Duties require verbal and written communication ability, visual acuity to product detail, manual coordination to operate hand tools and testing equipment, ability to enter data in computer system and the physical ability to lift various weights. Essential Job Functions Performs quality check of printed, laminated and slit roll samples and pouches on a regular basis to verify Operator's result for dimension. Operates quality control testing equipment/tools. Collects and manages sample retained. Collaborate with Operator and Production Supervisor in ensuring product conformance during job set up for approval to run. Respond and assist Production and/or Quality Supervisor in verifying reported non-conformities for quick resolution or corrective action. Communicate deviation incidents to concerned personnel for corrective action. Place non-conforming raw materials, WIP & Finished products ON HOLD/Quarantine on Radius, update the Quality Log and communicate to concerned personnel. Assist Quality Supervisor in sampling and verification of internally quarantined and customer returned non-conforming materials to identify proper disposition. Generates and issues Certificate of Analysis directly to customer or save in the system. Communicates discrepancies of production documentations (WI, SOP, Layout, etc.) to Management and CSR for timely correction. Prints quality forms for production personnel if needed. Read and replies to e-mails in timely manner. Cooperate in the maintenance, cleanliness and organization of the Laboratory. Cooperate during root cause analysis to identify proper corrective & preventive action. Assist in collection, preparation and review of customer required samples. Perform filing of quality documents/records. Assist with team members with their responsibilities as needed or during their absence. Attend team meetings and feedback on any quality related issues/improvements. Assist in employee trainings, if required. Follow all established safety rules and regulations and utilize required safety equipment. Report defective equipment or unsafe conditions to the appropriate personnel. Maintain work area in a clean and orderly condition. Follow all company Good Manufacturing Practices & Policies. Perform other duties as required or as requested by Supervisor or Manager. Ability to work a flexible schedule if needed. Ability to collaborate and maintain Garlock's commitment to a Food Safe environment. Skills and Knowledge Technical or vocational degree is a plus. Able to consistently act independently and prioritize work. Practical interpersonal and written communication skills Experience with ERP and other Maintenance Planning tools. Strong analytical and problem-solving skills Strong sense of ownership, work ethic, good judgment, and decision-making skills Familiar with Microsoft Office (Word, and Excel). Able to work in a fast-paced environment and multi-task effectively. Excellent organizational and prioritization skills. Excited about taking on new challenges in the manufacturing industry Self-motivated, hands-on, practical mindset, and capable of setting and reaching ambitious goals. Ability to work as part of a team and independently. Ability to collaborate and maintain Garlock's commitment to a Food Safe environment. Physical Requirements: While performing the duties of this job, the employee is regularly required to stand, walk, sit, and use hands to handle or feel. The employee frequently is required to talk or hear. The employee is occasionally required to reach with hands and arms. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. Work Environment: The noise level in the work environment is usually loud. Period lifting of pallets weight and material weighing up to 50lbs Squatting, crouching, turning, twisting, stretching, climbing steps, grabbing, pulling, pushing, and bending. Visual and hearing acuity within normal limits Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Typical environment of manufacturing and production facilities. Exposure includes but is not limited to continuous noise, scent of materials, bright workstations, machinery with moving parts. Other Details: Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. This company is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
    $32k-48k yearly est. 4d ago
  • Quality Technician

    Altium Packaging LP

    Quality Assurance Technician Job 40 miles from Fitchburg

    1253 W Central Street, Franklin, Massachusetts 02038 Work Shift: 8hr-2nd Shift (United States of America) The Quality Technician will audit, test and measure finished goods to ensure customer standards are met as well as follow our company's Good Manufacturing Practices. JOB SUMMARY: The Quality Technician will audit, test and measure finished goods to ensure customer standards are met as well as follow our company's Good Manufacturing Practices. ESSENTIAL DUTIES & RESPONSIBILITIES: Ensure compliance with corporate and plant safety standards and with applicable laws and regulations issued by regulatory agencies. Apply statistical tools and techniques to monitor plant performance and finished goods. Complete laboratory testing and collect samples at established intervals. Continually seek process improvements and make recommendations to management. Audit compliance with GMP policies. Performs process inspections during molding, packaging and loading. Audit for compliance to control plan requirements including process parameters. Perform incoming inspection of raw materials. Complete dimensional checks and report on product. Perform in-process inspections of manufactured product during molding, packaging and loading. Perform cycle counts and/or inventory of finished goods as required. Communicate quality issues and out of specifications conditions to appropriate personnel and with shift leaders. Other duties as assigned by management. Qualifications: The requirements listed below are minimum requirements for the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Education and/or Experience: The technician position requires a high school diploma or its equivalent. One year of related experience. ASQ certification or equivalent preferred Competencies: Safe work practices Influencing skills Knowledge of basic statistics Metrology skills including calibration Able to manage multiple priorities & meet deadlines Good computer skills Uses logical approach to problem solving in Production & Continuous Improvement Understands the role of Quality in a manufacturing organization and a Quality Operating System Altium Packaging, Our Culture Differentiates Us! We incorporate our Guiding Principles into all aspects and at all levels of the organization and use them as a framework for decision-making. We believe our Guiding Principles foster a culture of excellence that benefits both employees and customers. Our Guiding Principles Act with Integrity & in Compliance Drive Value Creation Be Disciplined Entrepreneurs Focus on the Customer Act with Humility Treat others with Dignity and Respect Seeking Fulfillment in your Work We Believe in Rewarding our Most Important Resource - Our People! We show our commitment to Total Rewards by providing a competitive, comprehensive benefits package. In addition to medical, dental and vision plans, company holidays and vacation days, tuition reimbursement, learning and training opportunities, bonus potential, and a 401(k) plan with company contributions, Altium Packaging locations offer rewards and recognition programs and opportunities to make a difference in the community. EEO Statement We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state or local protected class. Take your career to the next level at Altium Packaging!
    $33k-49k yearly est. 5d ago
  • Quality Technician

    DRS Technologies 4.6company rating

    Quality Assurance Technician Job In Fitchburg, MA

    The Leonardo DRS Naval Power Systems business is a trusted provider of innovative naval gas and hybrid power systems, control technology and support solutions for the U.S. Navy and navies around the world. The Quality Technician ensures process compliance, performs in-process and final inspections, and supports continuous improvement initiatives within a complex build-to-print manufacturing environment. This role is critical in maintaining high-quality standards and ensuring adherence to industry specifications and customer requirements. Job Responsibilities * Perform in-process and final inspections on mechanical, electrical, and optical assemblies to ensure conformance to engineering drawings, specifications, and industry standards. * Conduct process compliance surveillance to ensure adherence to documented procedures, work instructions, and best practices. * Quickly identify and communicate process deviations and non-conformances, working with production and engineering teams to implement corrective actions. * Interpret and apply GD&T (Geometric Dimensioning and Tolerancing) requirements on assembly drawings. * Utilize precision measuring instruments such as calipers, micrometers and height gauges. * Review and verify documentation for accuracy, completeness, and compliance with customer and regulatory requirements. * Assist Quality Engineers in developing inspection plans, conducting MRB (Material Review Board) investigations, and executing process surveillance activities. * Support calibration activities, ensuring equipment and tooling meet required specifications. * Work from complex wiring diagrams, operation sheets, engineering specifications, and sketches. * Provide guidance to production teams regarding quality control processes and best practices. * Maintain compliance with safety regulations, company policies, and industry certifications. * Assist in training new team members on quality inspection procedures and process adherence. * Adherence to production schedules while maintaining quality standards. * Pass/fail rates of inspected products. * Reduction of process non-conformances through proactive process surveillance, product inspection and reporting. * Compliance with industry standards such as IPC-610, ANSI J-STD-001, and other relevant specifications. * Effective coordination of multiple inspection activities in a dynamic production environment. Qualifications * Associate's degree in a technical discipline or equivalent experience in quality inspection or a related field. * Strong understanding of quality assurance principles, inspection techniques, and process compliance. * Experience working within a quality management system equivalent to ISO 9001 or AS9100, preferred. * Experience in handling delicate components with adherence to ESD (Electrostatic Discharge) best practices. * Proficiency in interpreting technical drawings, GD&T, and industry standards. * Knowledge of MRP systems and data analysis tools is a plus. * Proficiency in using various computer applications, including Access, Excel, and LabVIEW. * Strong decision-making skills with the ability to prioritize tasks in a fast-paced environment. * US Citizenship required. U.S. Citizenship required. Taking care of our people is a top priority at Leonardo DRS. We are proud to offer competitive salaries and comprehensive benefits, including medical, dental, and vision coverage, a company contribution to a health savings account, telemedicine, life and disability insurance, legal insurance, and a 401(k) savings plan. We champion wellness programs that focus on physical, emotional, and financial well-being. We develop our talent by offering programs and activities to support career-growth, professional development, and skill enhancement. And we understand there is more to life than work, and the importance of offering flexible work schedules with our 9/80 program, competitive vacation, health/emergency leave, paid parental leave, and community service hours. * Some employees are eligible for limited benefits only Leonardo DRS, Inc. and its subsidiaries provide equal opportunities to all employees and applicants for employment and prohibit discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, protected veteran status, or any other characteristic protected by federal, state, or local laws. #NPS #LI-LT1 #INDNPS Our Vision. To be the leading mid-tier defense technology company in the U.S. Our Values. The Leonardo DRS culture is defined by our Core Values and Principles: * Integrity * Agility * Excellence * Customer Focus * Community & Respect * Innovation We strive to uphold them in all aspects of our business practices to inspire our employees and provide outstanding support for our customers. Nearest Major Market: Worcester
    $30k-38k yearly est. 34d ago
  • Quality Technician

    Rogers Corporation 4.8company rating

    Quality Assurance Technician Job 44 miles from Fitchburg

    Job Category: Quality Shift: Shift 2 Full Time / Part Time: Full-Time Job Level: Individual Contributor Approximate Travel: 0% Job Description: This role is responsible for acting as a testing resource for the lab, supporting the current technicians and provide testing services used to facilitate production and certification of products. This role will also assist in maintaining documentation of test results, procedures and calibration of tools and equipment. **Essential Functions:** + Provides accurate and timely test results and assist production with in-process testing. + Maintains quality records and procedures. + Performs standard testing in a lab environment when needed + Certifies physical properties to customers and generates certificate of compliance. + Maintains records of calibration and repair and perform calibrations on equipment/tools. + Maintains labs inventory of test consumables. + Reviews compliance of materials to material specifications. + Other duties as assigned. **Qualifications:** + High School Diploma or equivalent. May consider equivalent experience in lieu of education. + 1+ Year experience in manufacturing environment. + Experience with data analysis and database computer programs. + Experience with quality and other laboratory testing tools. Additional Qualification Details: No additional requirement needed **Who We Are and What We Are All About:** Rogers Corporation makes tomorrow's innovations possible. Help build a cleaner, safer and more connected world with a career at Rogers, where we make tomorrow's innovations possible. We rely on a talented workforce to develop our cutting edge, market-leading material technologies. Our global team develops innovative specialty materials and components that enable technology in a wide array of high-growth markets. Our customers expect high performance and reliability, so we are always looking for people who can improve processes, get results and represent a best-in-class organization. People are at the heart of all our operations, and we encourage our employees to act with integrity, creativity and excellence to help drive results worldwide. **Why Work for Rogers:** It is our commitment to get "Results, but Results the Right Way." Rogers offers an exceptional work environment and a value-driven culture modeled by leadership. Employees have access to developmental opportunities as well as top-notch benefits and incentive programs. Come join a winning team! Rogers Corporation provides equal employment opportunities to minorities, females, veterans and disabled individuals, as well as other protected groups. **About Rogers Corporation:** At Rogers Corporation (NYSE:ROG), we're changing how the world uses technology. We are a global leader in materials technology and manufacturing, producing engineered materials to power, protect and connect our world. With nearly 200 years of materials science and engineering experience, Rogers delivers high-performance solutions that enable global Advanced Electronics Solutions and Elastomeric Material Solutions, as well as other technologies where reliability is critical. Rogers enables the world's leading innovators to achieve greater performance, speed to market and reliability through our renowned technical solutions support, problem-solving and application engineering capabilities. Rogers delivers market-leading solutions for energy-efficient motor drives, vehicle electrification and alternative energy, sealing, vibration management, and impact protection in mobile devices, transportation interiors, industrial equipment and performance apparel, wireless infrastructure and automotive safety and radar systems. Headquartered in Chandler, Arizona (USA), Rogers operates manufacturing facilities in the United States, China, Germany, Belgium, Hungary and South Korea, with joint ventures and sales offices worldwide. For more information, visit ****************** .
    $30k-38k yearly est. 16d ago
  • Travel Cath Lab Technologist - $3,105 per week

    Healthtrust Workforce Solutions HCA

    Quality Assurance Technician Job 34 miles from Fitchburg

    HealthTrust Workforce Solutions HCA is seeking a travel Cath Lab Technologist for a travel job in Derry, New Hampshire. Job Description & Requirements Specialty: Cath Lab Technologist Discipline: Allied Health Professional Duration: 13 weeks 40 hours per week Shift: 10 hours, days Employment Type: Travel About HealthTrust Workforce Solutions HCA At HealthTrust Workforce Solutions, healthcare is not just about the four walls of a facility but about the people who provide and receive care. Our focus is on empowering healthcare professionals to deliver exceptional patient experiences by providing them with the necessary skills, tools, and support. We partner with healthcare facilities nationwide to ensure that the right professionals are in the right roles. We prioritize our clinicians by giving them a voice and access to opportunities to fulfill their mission of improving lives by providing quality patient care. We are committed to our core values of Trust, Innovation, Adaptability, Courage, and Accountability. We are dedicated to positively impacting the healthcare industry by providing first-priority access to more than 200,000 jobs nationwide to our healthcare professionals. Join us and be part of the HealthTrust family, where you can make a difference every day. We embrace our changing environment, and we maintain a culture that has a rich tradition of transforming itself to meet the challenges of the future. MISSION STATEMENT While putting great people in the right roles is essential, our mission is far greater. We want our clinicians to be part of the HealthTrust family, where healthcare professionals have a voice and are empowered with the right tools and opportunities to fulfill their personal mission of improving lives. Plus, as a preferred partner to thousands of top-performing hospitals, we provide our healthcare professionals with first-priority access to more than 200,000 jobs nationwide. Benefits Dental benefits Vision benefits Referral bonus Continuing Education Life insurance
    $31k-44k yearly est. 4d ago
  • Quality Technician 2nd Shift

    Oatey 4.3company rating

    Quality Assurance Technician Job 34 miles from Fitchburg

    _Share by Email_ _Share on LinkedIn_ Share on X (***************************************************************************************************************************************************************** _Share on Facebook_ Apply (******************************************************************************************************************************************* Apply (Existing Employee) + Req #:R6295 + Facility Name:Winchester, NH (Manufacturing) + Facility Address:75 Plumb Pak DriveWinchester, NH + Job Type:Full time + Posted Date:3/7/2025 **Why Oatey?** Since 1916, Oatey has provided reliable, high-quality products for the residential and commercial plumbing industries, with a commitment to delivering quality, building trust and improving lives. Today, Oatey operates a comprehensive manufacturing and distribution network comprised of industry leading family of companies: Oatey, Cherne, Keeney, Quick Drain, Hercules, Dearborn, GF Thompson, William H. Harvey, Masters, Contact, Belanger, Lansas, and Durgo. At Oatey, we're doing big things - and by joining us, you'll have the chance to do big things too. You can build a strong career in an innovative, inclusive, high-performance environment, with the confidence that your company cares - about you, our customers and our world. **Ready to make an impact in a place where you matter?** Position Summary Ensures the quality of all processes, procedures, materials, processes rework and finished products. Also performs scheduled tasks as support for environmental and safety functions with additional responsibilities as assigned. Position Responsibilities Conduct daily quality inspections in all departments to audit the following: Procedure compliance/documentation with ISO9001 quality systems. In-process quality inspections, using established procedures. Incoming inspection, including first piece inspection, verification of Supplier's Certificates of Analysis, etc. Validation of product quality conformance to specifications. Complete ongoing Reliability Testing to ensure current products continue to meet product performance and/or formulation specs. Provide disposition and segregation of rejected materials and/or products. Summarize data and provide appropriate reports. Maintains rework inventory. Provides samples and sample data. Maintain calibration/verification records for all lab testing instrumentation and hand-held devices. Prepare test pipes (go-no go Gauges) for fit testing. Supply manufacturing with calibrated measuring and test equipment. Provide organizational quality support by assisting with problem resolution on the shop floor which includes gathering information on any quality-related issues, conducting root cause analysis and providing resolution for non-conformities. Participate in manufacturing CIP meetings as the QA representative and in ongoing quality training of manufacturing and QA staff. Maintain good housekeeping in lab, office and storage areas. Maintain and keep organized all QA files and documentation for easy reference and ISO9001 documentation compliance. Other duties as assigned. Knowledge and Experience Good communication and organizational skills. Computer literacy with Microsoft Office software applications. Excellent problem-solving and analytical skills. Basic understanding of quality concepts including variation, process control and root cause analysis. Cooperative attitude toward co-workers and supervisors. Knowledge of various equipment used in a laboratory (Fill machines, pallet jack, box knife, batch gun, mix tanks, drum mover, microscope, viscometer, Gas Chromatograph, and computer). Education and Certification High School Diploma required. Associate's Degree in a business, engineering or scientific course of study or equivalent experience in a manufacturing or laboratory environment preferred. At Oatey we are committed to help our Associates grow their career. Apply today and grow with Oatey! **Oatey Total Rewards** + Generous paid time off programs and paid company holidays to support flexibility and work-life balance + Annual Discretionary Cash Profit Sharing + 401(k) with competitive company match + Market leading health insurance including medical, dental, vision, and life insurance offerings for associates and qualified dependents + Significant company contribution to Health Savings Account with a High Deductible Health Plan (HDHP) + Short-Term and Long-Term Disability income protection coverage at no cost to associates + Paid Maternity and Paid Parental Leave + Tuition reimbursement + A robust suite of complementary benefits to support associate well being **Equal Opportunity Employer** The Oatey family of companies are an equal opportunity employer committed to Diversity, Equity, and Inclusion. We recruit, employ, promote, and offer competitive pay for all jobs without regard to race, color, creed, religion, sex, age, national origin, disability, sexual orientation, or any other characteristic protected by law.
    $39k-48k yearly est. 45d ago

Learn More About Quality Assurance Technician Jobs

How much does a Quality Assurance Technician earn in Fitchburg, MA?

The average quality assurance technician in Fitchburg, MA earns between $22,000 and $72,000 annually. This compares to the national average quality assurance technician range of $26,000 to $60,000.

Average Quality Assurance Technician Salary In Fitchburg, MA

$40,000
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