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Senior Specialist, Quality Assurance Investigations - Devens, MA
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Senior Specialist, Quality Assurance Investigations – Devens, MA
Senior Specialist, QA Investigations at Bristol Myers Squibb, located in Devens, MA, focuses on quality oversight of deviation investigations and associated actions at the Cell Therapy manufacturing facility.
Responsibilities
Review and approve investigations, CAPAs, and effectiveness checks across manufacturing, laboratory, facility, and computer systems.
Author, review, and approve technical reports, risk assessments, and deviation monitoring reports.
Ensure corrective/preventive actions robustly address root causes.
Perform routine reporting and analysis of quality event metrics to support timely closures.
Identify improvement opportunities and support execution of continuous improvement goals and projects.
Support internal and external inspections as required.
Maintain compliance with learning plan and deliver training content to cross‑functional teams.
Lead meetings, represent function at cross‑functional meetings, and build strong relationships with partner functions.
Qualifications
Bachelor’s degree in a STEM field preferred; High‑school diploma, associate’s degree, or equivalent combination of education and experience acceptable.
4+ years in a regulated industry with at least 1 year of deviation experience; experience in FDA/EMA biopharmaceuticals or cell‑therapy manufacturing preferred.
Experience with electronic systems and databases, root‑cause analysis tools (5‑WHY, Ishikawa, Process Flow Diagram, etc.).
Strong knowledge and application of regulatory guidelines and internal policies.
Proficient with MS Office, Smartsheets, and ability to learn new software quickly.
Excellent written and verbal communication, with ability to present technical data clearly.
Detail‑oriented, task‑focused, and able to meet deadlines in a fast‑paced environment.
Self‑motivated, collaborative, and able to work across functional groups.
Compensation Location‑based salary range: $75,000–$100,000 annually. Additional cash and stock incentives may be available based on eligibility.
Location Devens, Massachusetts, United States.
EEO Statement Bristol Myers Squibb is an Equal Opportunity Employer. We welcome applicants from all backgrounds.
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Responsibilities
Review and approve investigations, CAPAs, and effectiveness checks across manufacturing, laboratory, facility, and computer systems.
Author, review, and approve technical reports, risk assessments, and deviation monitoring reports.
Ensure corrective/preventive actions robustly address root causes.
Perform routine reporting and analysis of quality event metrics to support timely closures.
Identify improvement opportunities and support execution of continuous improvement goals and projects.
Support internal and external inspections as required.
Maintain compliance with learning plan and deliver training content to cross‑functional teams.
Lead meetings, represent function at cross‑functional meetings, and build strong relationships with partner functions.
Qualifications
Bachelor’s degree in a STEM field preferred; High‑school diploma, associate’s degree, or equivalent combination of education and experience acceptable.
4+ years in a regulated industry with at least 1 year of deviation experience; experience in FDA/EMA biopharmaceuticals or cell‑therapy manufacturing preferred.
Experience with electronic systems and databases, root‑cause analysis tools (5‑WHY, Ishikawa, Process Flow Diagram, etc.).
Strong knowledge and application of regulatory guidelines and internal policies.
Proficient with MS Office, Smartsheets, and ability to learn new software quickly.
Excellent written and verbal communication, with ability to present technical data clearly.
Detail‑oriented, task‑focused, and able to meet deadlines in a fast‑paced environment.
Self‑motivated, collaborative, and able to work across functional groups.
Compensation Location‑based salary range: $75,000–$100,000 annually. Additional cash and stock incentives may be available based on eligibility.
Location Devens, Massachusetts, United States.
EEO Statement Bristol Myers Squibb is an Equal Opportunity Employer. We welcome applicants from all backgrounds.
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