92 assurance associate jobs at 60 companies in Reading, MA
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Program Quality Associate Director, Assurance
Boston, Massachusetts, United States
$155k-$233k/yrHybridFull Time
Vertex PharmaceuticalsNASDAQ: VRTX: Develops and sells prescription drugs for serious genetic diseases.
5+ YOE3+ Mgmt5+ years pharmaceutical/biotech experience and 5+ years patient support quality management; experience with audit, CAPA, risk-based assurance, strong analytical and leadership skills.
Microsoft Excel, Power BI, Tableau, Service Cloud, Health Cloud, Life Sciences Cloud
Ocular TherapeutixNASDAQ: OCUL: Develops hydrogel-based drug delivery systems for treating eye diseases
5+ YOEBachelor's in a scientific discipline, 5+ years pharma/biotech/medical device QA experience, strong GMP/GLP knowledge, analytical testing familiarity, OOS/CAPA experience, and proficiency with MS Office.
Microsoft Office, Microsoft Excel, Microsoft PowerPoint
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.
ReplimuneNASDAQ: REPL: Develops oncolytic immunotherapies for cancer treatment.
3+ YOEBA/BS or equivalent, minimum 3 years pharma/biotech regulated experience with 3 years in QA/QC/manufacturing, working knowledge of cGMP and GDP, strong communication and multitasking skills.
PwC: Providing audit, tax, and management consulting services to businesses.
2+ YOEBachelor's degree, 2+ years experience, proficiency in QA methodologies including automation and testing for AI-enabled applications; experience with Selenium, data validation, and strong analytical and communication skills.
AbbottNYSE: ABT: Manufactures medical devices, diagnostics, and nutritional health products.
5+ YOEAssociate degree in engineering (or equivalent), 5+ years quality supervisory experience in medical devices or pharma, auditing experience, FDA/QMS compliance, strong communication and organizational skills.
AbbottNYSE: ABT: Provides medical devices, diagnostics, and science-based nutritional products.
5+ YOE5+ MgmtAssociate degree in engineering or equivalent, 5+ years quality supervisory experience in medical devices/pharma, quality systems/auditing experience, FDA compliance knowledge, strong communication and organizational skills.
AgeSpan: Provides social and health services for aging adults' independence.
2+ YOERequires 2 years of case management or PCA skills trainer experience, or 5 years with an associate degree. Bachelor's preferred; LSW preferred. Strong QA, documentation, communication, and database skills required.
word processing, database entry, e-mail applications
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.
ZOLL Medical: Manufactures medical devices and software for emergency care.
4+ YOESupervise QA technicians, review and close product complaints, perform root cause and failure analysis, and coordinate corrective actions; 4+ years experience and associate's degree preferred; knowledge of FDA QSR and MS Office.
MS Windows, Microsoft Excel, Microsoft Access, Microsoft PowerPoint, Microsoft Word
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.
Bristol Myers SquibbNew York Stock Exchange: BMY: Develops and distributes innovative medicines for serious diseases.
4+ YOE4+ years cGMP experience (1+ year site manufacturing preferred). Bachelor's in STEM preferred (HS/Associates with experience considered). Proficiency with quality systems, data interpretation, MS Office and digital tools; strong communication and decision-making skills.
BMSDocs, CELabs, MES, SAP, ValG, DeltaV, Maximo, Infinity, Microsoft Power Automate, Smartsheet, Tableau, MS Office
Leonardo DRSNASDAQ: DRS: Manufactures advanced electronic systems for defense and military applications.
Associate degree in technical discipline or equivalent experience; strong decision-making and leadership; handling of small components; ESD practices; soldering/wire bonding a plus; safe handling of chemicals; proficiency in Access, Excel, and LabVIEW; MRPs experience a plus; good mechanical skills.
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)
TeleflexNYSE: TFX: Manufactures medical devices for critical care and surgical procedures.
1+ YOE1+ year training/document control or quality support experience in a regulated industry; high school diploma (associate preferred); knowledge of QMS, controlled documentation, FDA and ISO 13485 requirements; strong accuracy and reporting skills.
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.