QA Specialist I - GMP Manufacturing & Cleanroom
Vericel® Corporation
Vericel Corporation, a leader in advanced cell therapies, seeks a QA-focused professional for day-to-day batch record review, labeling, archiving, and final product inspection in our Burlington, MA facility. You'll gown into ISO 7 clean rooms and support release activities on a Tuesday–Saturday or Sunday–Thursday schedule, with some training/monthly relocation to Cambridge. Strong GMP knowledge and Excel skills are required. #J-18808-Ljbffr Vericel® Corporation
- Anika in Bedford, MA is seeking a Senior Quality Assurance Specialist to provide QA oversight across CMC development, manufacturing, and supply chain. You will serve as a subject matter expert in GMP quality systems, regulatory readiness, and continuous improvement of...Suggested
$110k - $120k
Editas Medicine in Cambridge, MA seeks a QA professional to oversee GMP operations, review batch records, and disposition lots. You will collaborate... ...with CDMOs/CTOs and author GMP documentation to support manufacturing and quality events. The role requires a BS in a...Suggested$80k - $95k
...provide process development, produce GMP viral vectors, and provide cell... ...support of biologics/gene therapy manufacturing operations, the Quality Assurance Specialist II engages in collaborative day to... ...batch disposition activities. QA support of drug product aseptic fill...SuggestedLive inVisa sponsorshipMonday to FridayAfternoon shift- What You’ll DoThe Senior Quality Assurance Specialist provides quality assurance oversight... ...Quality Control, Analytical Development, manufacturing, and supply chain activities, ensuring compliance... ...you serve as a subject matter expert in GMP quality systems, CMC quality oversight,...SuggestedFull timeContract workImmediate start
- ...Therapy in Bedford, MA is seeking a Senior Specialist, Quality Assurance Operations to oversee QA activities for drug substance manufacturing at a new gene therapy facility. You will... ...QC, Quality Systems, and MSAT to ensure GMP compliance and timely investigations. On-...Suggested
$110k - $120k
...Our goal is to discover, develop, manufacture, and commercialize... ...management. This role is part of a small QA team with opportunities for cross... ...Your Impact: As the Senior QA Specialist, you will: Maintain Quality oversight of GMP operations including batch...Flexible hours- Nova Biomedical is seeking a QA Specialist to strengthen our Quality Management System and ensure regulatory compliance across our operations... ...continuous improvement with cross-functional teams across Manufacturing, Engineering, Regulatory Affairs and Quality Control. Ideal...
- ...The Quality Assurance Specialist will actively contribute to the implementation... ...Systems Manual and conduct GMP compliance audits as directed. The QA Specialist will have oversight of... ...including work performed by Contract Manufacturing Organizations (CMOs). Provide assistance...Contract work
$28.85 - $34 per hour
...able to gown into classified manufacturing ISO 7 clean room areas, to conduct... ...product within an ISO 7 cleanroom. Support day to day operations... .... Support projects as a QA resource. Identifies... ...Basic working knowledge of GMP regulations. Preferred Qualifications...Hourly payFor contractorsWork at officeMonday to FridayWeekend work- ...Quality Assurance Professional will work in the US External QA team responsible for Contract Manufacturing (CMO) and Contract Test Laboratories (CTL) oversight... ...CTL metrics, data, and deliverables. Experience with GMP programs in cGMP biotech and/or pharmaceutical...Contract workFlexible hours
- Ultragenyx Pharmaceutical in Bedford, MA seeks a Quality Assurance Drug Substance (DS) Specialist to oversee QA activities for a gene therapy manufacturing site. You will review batch records, perform deviations management, and collaborate across Manufacturing, Engineering...
- The CMC QA Consultant will report to the Director of CMC QA and be responsible for supporting... ...functional team (i.e. PD, MSAT, CMC, Manufacturing, Regulatory Affairs etc) to confirm the... ...and at external partners Ensure GMP processes are implemented in the Quality...Contract workLocal area
$85k - $105k
Quality Assurance Specialist II, Device Engineering Location: Woburn, MA (relocating to a new facility... ...and test method validation activities Review GMP documentation, batch records, protocols, reports, and manufacturing records Support supplier quality programs, audits...Relocation$30 - $34 per hour
...Adecco is searching for Manufacturing Technicians in Billerica for a great company! This is a temp to hire opportunity. Hours: 7:00AM-3:30PM, Monday-Friday Pay: $30-$34/hour Job Summary: Provides technical support to the quality and quality engineering (QE)...Hourly payTemporary workLocal areaMonday to Friday$107.1k - $138.6k
...patients, our people, and our pigs.POSITION SUMMARYThe Senior Quality Systems Specialist will be supporting the QA team to implement and manage Quality Systems supporting GMP Manufacturing and Testing across all eGenesis locations.This position reports to the Associate...- ...Hiring: Document Control & Quality Systems Coordinator Passionate about industrial automation , precision, and building world‑class manufacturing systems? This role puts you at the center of quality excellence. Growing company with a path for success which rewards its...Immediate start
- ...connect with experienced Quality Assurance professionals with GMP manufacturing experience for an opportunity supporting quality and... ...commute to Boston Pandologic. Keywords: Quality Control / Quality Assurance Specialist, Location: Cambridge, MA - 02238 , PL: 604161302
- ...QA SpecialistPerform the QA review/approval of analytical documentation: Analytical method validation protocols and reports for... ...reference standard/critical reagent qualifications Collaborate with manufacturing support functions to develop the methods and acceptance...
- ...Quality Assurance Specialist Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected... ...: The Quality Assurance Professional will work in the Internal QA team of Human Genetic Therapies Quality Assurance Department. Responsibilities...
- ...Lancesoft Job Details: Title : Quality Assurance Specialist Location : Lexington, MA Duration: 3 years Contract... ...• Plan, design, deploy, maintain and troubleshoot related to QA tools like Tricentis TOSCA and Impact Analysis/Live Compare tool...Contract workApprenticeshipLocal area
- ...Davis Companies in Massachusetts, Burlington, is seeking a motivated Document Control & Quality Systems Coordinator to join our manufacturing quality team. You will manage controlled documents, coordinate corrective actions, support internal and external audits, and ensure...
$63.65k - $92.57k
...these areas. Assist with the development and delivery of regular reports on performance, trends, and other actionable insights to the QA, Training, and Operations Leadership teams. Document evaluations utilizing departmental quality monitoring templates, established...Remote workShift work$77k - $86k
...biopharmaceutical and clinical markets. Job Summary The Quality Assurance (QA) Specialist supports the effectiveness, compliance, and continual... ...Prepare and review Engineering Change Orders (ECOs), Manufacturing Variances (MVs), and other controlled changes Support...Hourly payWork at officeLocal areaFlexible hours$72k - $91.5k
...Quality Control Specialist Lexington, MA Kiniksa Pharmaceuticals is a commercial-stage... ..., the Stability Coordinator manages the GMP stability programs, supporting trending... ...Analytical Development, Quality Control, Manufacturing, CMC, Validation, and Quality Systems....Contract workWork at office$20 - $25 per hour
...Position Overview Now Hiring: Quality Specialist Lowell, MA $20.00-$25.00 per hour (DOE) Full-Time | Day Shift | 6:00... ...safety? Are you detail-oriented and enjoy working in a fast-paced manufacturing environment? PGI Foods is looking for a Quality...Hourly payFull timeImmediate startDay shift- The Steely Group is seeking a CMC QA Consultant to support cross-functional teams across PD, MSAT, CMC, Manufacturing and Regulatory Affairs to ensure quality and compliant controls for gene therapy programs. You will review batch records, deviations, tech transfers, and...
$111k - $185k
...of role The Supplier Quality Senior Specialist is responsible for maintaining Lantheus’... ...international suppliers consist of Contract Manufacturing Organizations (CMO), drug substance... ...and minimum of 7+ years’ experience in a GMP environment, preferably in a Quality- related...Contract workFor contractorsLocal areaRemote work- ...QA Documentation Associate A Few Words About Us Integrated Resources, Inc is a premier... ...and regulations, review/approval of GMP procedures, protocols and reports, support... ...audits. Interfacing with key Quality, manufacturing, and PO&T customers. Supporting the Quality...
- ...Dosimetrists to ensure precise prescriptions and safe, effective treatments. Under the Chief Medical Physicist, you will participate in QA/QC, radiation safety, budgeting, and education activities, while supporting ongoing professional development. #J-18808-Ljbffr Beth...
- Entegris is seeking Manufacturing Technicians for our facilities in Billerica, MA and Bedford, MA. The role involves operating and maintaining UPE Membrane equipment, executing processes from extrusion to packaging, and ensuring compliance with quality standards. You will...
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