Senior Specialist, Quality Assurance Investigations, Cell Therapy
Bristol Myers Squibb
6 days ago
On-site
Devens, MA
Operations
Position Summary
The Senior Specialist, Quality Assurance Investigations, is responsible for quality oversight and approval of Deviation investigations and associated Action and Effectiveness Check records at the Devens Cell Therapy Facility. Ensures quality oversight and assurance of manufactured products in compliance with applicable regulations and BMS policies/guidelines.
Key Responsibilities
- Review and approve investigations/CAPAs/effectiveness checks for the manufacturing site (materials, manufacturing, laboratory, facility, computer systems).
- May author/review/approve technical reports (e.g., risk assessments, deviation system monitoring reports) to support the deviations program.
- Ensure corrective/preventive actions are robust and address root cause.
- May perform routine reporting and analysis of metrics to ensure timely closure of quality events/actions.
- Identify improvement opportunities and support site/team continuous improvement projects.
- Support internal and external inspections as required.
- Maintain compliance with assigned learning plan; support development/delivery of training content to cross-functional teams.
- Lead meetings and represent the function at cross-functional meetings; share data/knowledge; build strong relationships with partner functions.
Qualifications & Experience
- Ability to research, interpret, and apply internal policies and regulatory guidelines.
- Proficient computer skills; MS Office, Smartsheet, and ability to learn new software.
- Ability to interpret data/results, critically assess and provide feedback on proposed CAPA.
- Ability to critically review investigation reports and challenge technical conclusions using quality risk management principles.
- Excellent verbal and technical writing; present technical data clearly to management.
- Work effectively in fast-paced environments with changing priorities; detail-oriented and deadline driven.
- Able to work across functional teams; self-motivated.
Education/Experience
- STEM bachelor’s preferred (or HS/Associate’s with equivalent experience).
- 4+ years in a regulated industry; 1+ year deviation experience.
- Preferred: FDA/EMA experience in biopharma or cell therapy manufacturing.
- Demonstrated experience with electronic systems/databases.
- Root cause analysis tools experience (e.g., 5-Why, Ishikawa/Fishbone, process flow diagrams).
The Senior Specialist, Quality Assurance Investigations, is responsible for quality oversight and approval of Deviation investigations and associated Action and Effectiveness Check records at the Devens Cell Therapy Facility. Ensures quality oversight and assurance of manufactured products in compliance with applicable regulations and BMS policies/guidelines.
Key Responsibilities
- Review and approve investigations/CAPAs/effectiveness checks for the manufacturing site (materials, manufacturing, laboratory, facility, computer systems).
- May author/review/approve technical reports (e.g., risk assessments, deviation system monitoring reports) to support the deviations program.
- Ensure corrective/preventive actions are robust and address root cause.
- May perform routine reporting and analysis of metrics to ensure timely closure of quality events/actions.
- Identify improvement opportunities and support site/team continuous improvement projects.
- Support internal and external inspections as required.
- Maintain compliance with assigned learning plan; support development/delivery of training content to cross-functional teams.
- Lead meetings and represent the function at cross-functional meetings; share data/knowledge; build strong relationships with partner functions.
Qualifications & Experience
- Ability to research, interpret, and apply internal policies and regulatory guidelines.
- Proficient computer skills; MS Office, Smartsheet, and ability to learn new software.
- Ability to interpret data/results, critically assess and provide feedback on proposed CAPA.
- Ability to critically review investigation reports and challenge technical conclusions using quality risk management principles.
- Excellent verbal and technical writing; present technical data clearly to management.
- Work effectively in fast-paced environments with changing priorities; detail-oriented and deadline driven.
- Able to work across functional teams; self-motivated.
Education/Experience
- STEM bachelor’s preferred (or HS/Associate’s with equivalent experience).
- 4+ years in a regulated industry; 1+ year deviation experience.
- Preferred: FDA/EMA experience in biopharma or cell therapy manufacturing.
- Demonstrated experience with electronic systems/databases.
- Root cause analysis tools experience (e.g., 5-Why, Ishikawa/Fishbone, process flow diagrams).