68 assurance associate jobs at 48 companies in Bristol, RI
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Senior Associate, Quality Assurance
Framingham or Woburn
$106k-$137k/yrOnsiteFull Time
ReplimuneNASDAQ: REPL: Develops oncolytic immunotherapies for cancer treatment.
3+ YOE3–5 years of biotech or pharmaceutical quality experience, a formal degree or applicable associate-level experience, strong communication and organizational skills, attention to detail, and Microsoft Office competence.
Charles River Center: Provides residential and vocational support for people with disabilities.
3+ YOE3+ years human services experience preferred; experience with DDS regulations, audits, data analysis, documentation review, training, and quality improvement.
Seaport Therapeutics: Develops oral neuropsychiatric medicines using a proprietary technology platform.
8+ YOEBachelor's degree in science or related field, 8–10 years in pharmaceutical or biotechnology industry, significant quality experience, and strong GMP, regulatory, CMO, analytical, organizational, and problem-solving expertise.
Genetix Biotherapeutics: Developing and commercializing curative gene therapies for rare diseases.
4+ YOEBachelor's degree in life sciences, engineering, or related field; 4-6 years of QA experience in GMP-regulated biopharmaceutical or cell/gene therapy manufacturing; CMO oversight experience and cGMP knowledge.
1+ YOEKnowledge of cGMP/ICH Q7, experience writing/reviewing GMP documents, BS/BA in science or Associate plus experience, 1-5+ years QA cGMP experience, strong communication and problem solving.
Mass General Brigham: Provides integrated medical care, research, and clinical training services.
5+ YOEAssociate or Bachelor in Health Sciences; MA Radiography/Mammography license; ARRT-R and ARRT-M; 5-7 years radiology or related leadership/quality experience.
North Chicago or Cambridge or Worcester or Florham Park or Irvine or San Francisco or United States
$142k-$269k/yrHybridFull Time
AbbVieNYSE: ABBV: Develops and sells innovative pharmaceutical and biopharmaceutical medicines.
7+ YOEBachelor’s degree in science or healthcare, 7+ years in pharmaceutical clinical development, regulatory affairs, or quality assurance, with extensive clinical regulations, auditing, leadership, and risk management expertise.
Associate Director, Manufacturing Process and Technical Quality Assurance Cell and Genetic Therapies - VCGT
Boston, Massachusetts, United States
$157k-$235k/yrHybridFull Time
Vertex PharmaceuticalsNASDAQ: VRTX: Develops and sells prescription drugs for serious genetic diseases.
8+ YOEBachelor’s degree in a scientific or allied health field and 8+ years in a regulated pharmaceutical environment, with GxP quality assurance, cell therapy, investigations, risk management, and process lifecycle experience.
MES, eQMS, LIMS, data visualization platforms, process monitoring tools, advanced analytics, AI-enabled solutions
Candel TherapeuticsNASDAQ: CADL: Develops viral immunotherapies for the treatment of cancer.
6+ YOE6+ years QA experience with BS/BA in scientific or engineering (or 8+ years with Associate); knowledge of 21 CFR Part 11/Annex 11/CFR210/211, GxP, eQMS, internal audit, and regulatory guidelines; strong communication and organizational skills.
Electronic Quality Management System (eQMS), SmartSheet, SharePoint, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook, Microsoft Teams
Cogent BiosciencesNASDAQ: COGT: Develops precision therapies for genetically defined diseases
8+ YOEProvide GCP QA leadership, lead audits and inspection readiness, manage CAPAs and vendor oversight; requires 8+ years GCP QA experience and a scientific bachelor's degree.
HologicNASDAQ: HOLX: Develops medical technology for women's healthcare and diagnostics.
Experience in quality assurance, quality systems, CAPA, root cause analysis, audits, data analysis, KPIs, procedures, training materials, and regulated industries; strong communication and independent judgment required.
Quality Management Systems (QMS), Corrective and Preventive Action (CAPA), Quality Plans (QPLs), Key Performance Indicators (KPIs)
Genezen: Produces viral vectors for cell and gene therapy programs.
6+ YOEBachelor's degree in science or related field; 6–8+ years in pharmaceutical or biologics quality assurance; GMP, investigations, quality systems, cross-functional leadership, and mentoring experience.
Veeva, 21 CFR Part 11, 21 CFR 210, 21 CFR 211, 21 CFR 600, 21 CFR 610, EudraLex Volume 4, ICH Quality Guidelines, EMA, ISO
AmgenNASDAQ: AMGN: Develops and manufactures biotechnology medicines for serious diseases.
Requires high school/GED plus 2 years’ relevant experience, associate degree plus 6 months’ experience, or bachelor’s degree. Biotechnology or pharmaceutical laboratory experience preferred.
Polymerase Chain Reaction (PCR), Laboratory Information Management System (LIMS), Laboratory Management Execution System (LMES), TrackWise, Lean Manufacturing, 5S
Solid BiosciencesNASDAQ: SLDB: Develops precision genetic medicines for neuromuscular and cardiac diseases.
10+ YOE3+ MgmtRequires a science-related bachelor's degree or equivalent experience, 10–15 years of biotech technical QA experience, 3+ years leading outsourced activities, GMP expertise, biologics experience, and regulatory inspection experience.
Composite Energy Technologies: Engineers and manufactures advanced composite structures for maritime applications.
5+ YOEHigh school diploma and 5-7 years in related field; ASQ Certified Inspector; ISO 9001 internal auditor; proficient with testing tools; English proficiency; Lean knowledge preferred.
Calipers, Micrometers, Depth Gauge, Pin Gages, Scales, 3D Scanning, Height Gauges, Microsoft Word, Excel, PowerPoint, Teams, SharePoint, Outlook
OrganogenesisNASDAQ: ORGO: Manufacturer of advanced regenerative medicine and wound care products.
1+ YOEBiotechnology certificate or 1–2 years relevant experience; biology or related science degree preferred. Requires cleanroom capability, aseptic technique, GMP knowledge, basic lab skills, dexterity, and lifting up to 40 pounds.
Legal Sea Foods: Operates a chain of full-service seafood restaurants.
Requires an associate degree in biology, food science, or related field; laboratory or food production experience is a plus. Must lift 50 pounds and understand lab procedures and aseptic technique.