Senior Specialist, Field Quality QA Operations

Bristol Myers Squibb • Devens, MA

3d

About The Position

This position maintains quality oversight and ensures GMP compliance in day-to-day manufacturing operations. The Senior Field QA Specialist reviews Manufacturing Batch Records (MBRs), performs real-time on-the-floor exception reviews and logbook reviews, conducts GMP area walkthroughs, and supports return-to-service (RTS) walkthroughs to confirm manufacturing areas and equipment are cleaned, calibrated, and ready for production. The role works closely with Manufacturing Operations to investigate and resolve manufacturing issues, contributes to authoring and revising quality SOPs, supports review and closure of no-impact manufacturing deviations, and conducts proactive area inspections and readiness reviews. This floor-based role supports real-time quality assurance, batch release readiness, and audit preparedness.

The position is based in a modern manufacturing facility and involves awareness of workplace hazards, including pressurized liquids and gases, steam, and hazardous chemicals. Personal protective equipment is required in some facility areas, including appropriate gowning for cleanroom work. The listed shift is Monday through Friday, 7:00 a.m. to 3:30 p.m.

Requirements

• Four years of Quality Assurance experience in the pharmaceutical or medical device industry.
• Experience reviewing batch records.
• Knowledge of U.S. and EU cGMP regulations and guidance.
• Ability to apply defined processes and exercise judgment within established practices and policies.
• Bachelor's degree in science, engineering, biochemistry, or a related discipline, or equivalent, is preferred.

Nice To Haves

• Knowledge of biotech bulk and finished-product manufacturing and analytical testing.
• Knowledge of electronic or paper batch record systems, DeltaV, and other electronic systems used for laboratory test result generation, inventory management, investigations, and equipment tracking and maintenance.

Responsibilities

• Provide quality floor support for complex manufacturing activities.
• Review manufacturing batch production records in support of product release in accordance with specifications and SOPs.
• Conduct GMP area walkthroughs and document observations and areas of concern.
• Train new team members on routine facility Quality tasks.
• Support return-to-service walkthroughs and Manufacturing inspection-readiness walkthroughs as needed and according to procedures.
• Ensure electronic and paper documentation requiring QA review complies with corporate and site procedures, cGMP regulations, and industry guidelines.
• Work with Manufacturing Operations to investigate and resolve manufacturing issues.
• Contribute to authoring and revising quality SOPs.
• Support review and closure of no-impact manufacturing deviations.
• Conduct proactive area inspections and readiness reviews.
• Coordinate with higher-level leads or a supervisor on decisions and notify management as appropriate.

Benefits

• Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance, subject to plan terms and eligibility.
• Flexible Time Off for eligible U.S.-based exempt employees, subject to manager approval.
• Paid vacation for eligible non-exempt employees, RayzeBio employees, and employees located in Puerto Rico: 160 hours annually for new hires, subject to manager approval.
• 11 paid company holidays each year; eligible employees in specified groups also receive three optional holidays.
• Depending on eligibility, paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs.
• Eligible employees may receive an annual Global Shutdown between Christmas Day and New Year's Day.
• Potential eligibility for discretionary incentive cash and stock opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior