Specialist, Quality Assurance Shop Floor, Cell Therapy
Bristol Myers Squibb
September 04, 2026
Full-time
On-site
Devens, MA
Operations
Role: The Specialist, QA Shop Floor, supports 24/7 manufacturing operations in cell therapy, overseeing quality compliance on the production floor. Responsibilities include triaging unexpected events, reviewing and approving GxP records such as deviations and batch records, performing operational verifications, conducting area walk-throughs, and supporting inspections. The role emphasizes real-time quality oversight, issue resolution, and continuous improvement initiatives. Reporting to the QA Shop Floor Manager, the position requires close collaboration with manufacturing, QC labs, and supply chain teams.
Qualifications: Requires a Bachelor's in STEM (or equivalent experience), with 2+ years of relevant cGMP manufacturing experience, preferably in biopharmaceuticals or cell therapy. Must possess strong decision-making, problem-solving, and communication skills, along with proficiency in electronic systems like MES, SAP, and LIMS. Experience with GxP records, deviation management, and working within cleanroom environments is essential.
HighValue: Focus on cell therapy manufacturing, GxP compliance, deviation and batch record review, and electronic systems used in quality oversight. The role involves shift work (night shift, 12-hour pattern) at the Panama site, with an emphasis on operational decision-making and cross-functional collaboration.
Qualifications: Requires a Bachelor's in STEM (or equivalent experience), with 2+ years of relevant cGMP manufacturing experience, preferably in biopharmaceuticals or cell therapy. Must possess strong decision-making, problem-solving, and communication skills, along with proficiency in electronic systems like MES, SAP, and LIMS. Experience with GxP records, deviation management, and working within cleanroom environments is essential.
HighValue: Focus on cell therapy manufacturing, GxP compliance, deviation and batch record review, and electronic systems used in quality oversight. The role involves shift work (night shift, 12-hour pattern) at the Panama site, with an emphasis on operational decision-making and cross-functional collaboration.