Specialist, Investigations, Cell Therapy in Devens, MA

Role: Investigations Specialist within Bristol Myers Squibb's Cell Therapy manufacturing, leading and supporting deviation investigations to ensure cGMP compliance. Responsibilities: conduct root cause analyses, draft investigation reports and CAPAs, coordinate with manufacturing and quality teams, track CAPA implementation, and contribute to continuous process improvements. Requirements: bachelor's degree in science, engineering, or related field, with 1-3 years of biopharmaceutical operations experience; familiarity with investigation processes, CAPA systems, and quality documentation. Preferred skills include proficiency with electronic quality systems (e.g., Infinity, TrackWise, Veeva), understanding of Quality Risk Management, and operational excellence principles. High-Value: focus on cell therapy, biopharma manufacturing, cGMP compliance, investigations in a GMP environment, and cross-departmental collaboration. Work setup involves a Monday-Friday schedule, with approximately 15% of time in a clean-room environment and the remainder in an office.