Senior Specialist, QA Investigations
Bristol Myers Squibb · Summit West, NJ
QualityFull-time$84k–$102kCompany career page
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Role summary
Bristol Myers Squibb seeks a Senior Specialist, QA Investigations for its Summit Cell Therapy Facility in New Jersey. The role involves reviewing and approving deviation investigations, corrective/preventive actions, and technical reports to ensure product quality and regulatory compliance in a manufacturing environment.
What they're looking for
- Bachelor's degree in STEM field preferred; high school diploma or associate's degree with equivalent work experience considered
- 4+ years regulated industry experience with 1+ year deviation investigation experience
- FDA/EMA biopharmaceutical or cell therapy manufacturing regulatory knowledge preferred
- Proficiency with MS Office, Smartsheets, and ability to learn new software applications
- Root cause analysis expertise including 5-WHY, Ishikawa diagrams, and process flow analysis
- Strong technical writing and verbal communication skills
- Experience with electronic systems, databases, and risk management principles
What you'll be doing
- Review and approve deviation investigations, CAPAs, and effectiveness checks for manufacturing processes
- Assess corrective/preventive action plans to ensure they adequately address root causes
- Review and approve technical reports including risk assessments and system monitoring reports
- Perform metrics reporting and analysis to track timely closure of quality events
- Support internal and external inspections and lead cross-functional meetings
Privacy & handoff
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