Senior Specialist, Field Quality QA Operations

Summary

This position is critical to maintaining quality oversight and ensuring GMP compliance in day‑to‑day manufacturing operations. The Senior Field QA Specialist reviews Manufacturing Batch Records (MBRs), performs real‑time on‑floor exception reviews and logbook checks, conducts GMP area walkthroughs, and supports return‑to‑service (RTS) walkthroughs to confirm that manufacturing areas and equipment are properly cleaned, calibrated, and ready for production. The role works closely with Manufacturing Operations to investigate and resolve manufacturing issues as they arise, authorizes and revises quality SOPs, and conducts proactive inspections to uphold internal quality standards and external regulatory requirements.

Shift Available:
Monday – Friday, On‑site Afternoon Shift (2 p.m. – 10:30 p.m.).

• Provide quality floor support for complex manufacturing activities.
• Review manufacturing batch production records to support product release in accordance with specifications and SOPs.
• Perform walkthroughs of GMP areas, documenting observations and areas of concern.
• Provide training on routine facility quality tasks for new team members.
• Support return‑to‑service and manufacturing inspection readiness walkthroughs as needed.
• Ensure all electronic and paper documentation requiring QA review complies with corporate and site procedures, cGMP regulations, and other industry guidelines.

• Knowledge of biotech bulk and finished product manufacturing, and analytical testing is highly desirable.
• Knowledge of U.S. and EU cGMP regulations and guidance.
• Familiarity with electronic or paper batch record systems, DeltaV, and other electronic systems used for lab test result generation, inventory management, investigations, and equipment tracking/maintenance.
• Ability to interact with employees at all levels of the Devens Facility, collaborating with Quality, Supply Chain, Digital Plant, Site Engineering, and Manufacturing teams during day‑to‑day operations.
• Exercise judgment within defined practices and policies, coordinate with higher‑level leads or supervisors, and apply appropriate management notification.
• Handle assignments that require application of a defined process, with supervisory attention determined by demonstrated capability.

• Bachelor’s degree in science, engineering, biochemistry, or related discipline (or equivalent). Desired.
• 4 years of Quality Assurance experience within the pharmaceutical or medical device industry.
• Experience reviewing batch records.

• The role is performed in a modern manufacturing facility; awareness of workplace standards involving pressurized liquids, gases, steam, and hazardous chemicals is required.
• Use of Personal Protective Equipment (PPE) is required in some areas, including appropriate gowning for clean‑room environments.

Competitive benefits include medical, pharmacy, dental, vision coverage, wellness programs, financial protection (401(k), disability, life insurance, etc.), paid time off, and additional global benefits. For further details, visit BMS Careers Benefits.

We will never request payments, financial information, or social security numbers during our application or recruitment process. BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws. We provide a transparent recruitment process and reasonable workplace accommodations for people with disabilities. For more information, visit EEO Accessibility and Fraud Protection.

R1603371 :
Senior Specialist, Field Quality QA Operations