Senior Quality Assurance Specialist

5 days ago


Summit, New Jersey, United States Bristol Myers Squibb Full time
Job Summary

Bristol Myers Squibb is seeking a highly skilled Senior Specialist, QA Deviation Reviewer and Approver to join our team. As a key member of our Quality Operations group, you will be responsible for providing quality oversight for site manufacturing operations and quality control laboratory operations at our Summit S12 Cell Therapy manufacturing facility.

Key Responsibilities
  • Provide quality oversight for site manufacturing operations and quality control laboratory operations
  • Review and approve site operational investigations
  • Review and approve supplemental actions
  • Review and approve impact assessments or product quality evaluation approvals
  • Review and approve corrective and preventive actions (CAPA plans, action approvals, effectiveness check plans, and execution approvals)
  • Participate in audits and inspections, including inspection readiness activities
  • Attend and participate in investigation and CAPA review board meetings
  • Review and approve investigation protocols/plans and summary reports
  • Review and approve interim controls (mitigation protocols) for continued production
  • Review and approve proactive initiatives
  • Review and approve standalone actions
  • Contribute to deviation management procedure improvement
  • Ensure appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations
Requirements
  • Bachelor of Science in Physical Sciences, Engineering, or related discipline
  • Minimum of 5 years' experience in a related cGMP environment: Cell Therapy, Pharmaceutical, Biologics, Medical Device operations
  • Minimum of 4 years in QA/QC
  • At least 1-2 years investigation experience
Preferred Requirements
  • Advanced degree in a science area
  • Knowledge of Cell Therapy operations (manufacturing, QC, packaging/shipping)
  • Knowledge of LIMS and laboratory data analysis systems
  • Support in Health Authority Inspections
  • Ability to understand the manufacturing process of both Abecma and Breyanzi
About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company dedicated to transforming patients' lives through science. We are committed to advancing the treatment of cancer, cardiovascular disease, and other serious conditions. Our company is built on a foundation of innovation, collaboration, and a passion for making a difference in the lives of patients.

We are an equal opportunity employer and welcome applications from diverse candidates. If you are a motivated and experienced professional looking for a challenging and rewarding role, we encourage you to apply.



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