Specialist, Field Quality

Bristol Myers Squibb • Devens, MA

3d

About The Position

Provide Quality assistance and oversight to operations for in-process intermediates, manufactured products, and other GMP processes as required. Review and approve documentation associated with in-process materials and manufactured products, and assist with identifying, generating, and quality-reviewing investigation records arising during day-to-day operations. Ensure manufactured products comply with applicable regulations and guidelines.

The role provides quality floor support for routine manufacturing activities, reviews manufacturing batch production records for media, buffer, and cryo in support of product release, and performs GMP-area walkthroughs. It also supports return-to-service and inspection-readiness walkthroughs, reviews electronic and paper documentation for compliance, and may support deviation reviews and product release.

The position is based in Devens, Massachusetts. Compensation is listed at $81,800–$99,117. The company describes comprehensive benefits, with eligibility and specific offerings subject to applicable plan terms.

Requirements

• Working knowledge of common computer systems such as Microsoft Word and Excel.
• Familiarity with US and EU cGMP regulations and guidance.

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 applicable to laboratory test-result generation, inventory management, investigations, equipment tracking, and maintenance.
• A B.S. in science, engineering, biochemistry, or a related discipline, or equivalent, is preferred.
• A combination of two years of relevant experience in a regulated environment or a mix of co-op and regulated-environment experience is preferred.

Responsibilities

• Provide Quality assistance and oversight to operations for in-process intermediates, manufactured products, and other GMP processes.
• Review and approve documentation associated with in-process materials and manufactured products.
• Assist in identifying, generating, and quality-reviewing investigation records arising during day-to-day operations.
• Ensure manufactured products comply with applicable regulations and guidelines.
• Provide quality floor support for minor and routine manufacturing activities.
• Perform routine manufacturing batch production record reviews for media, buffer, and cryo in support of product release, in accordance with specifications and SOPs.
• Perform walkthroughs of GMP areas and document observations and areas of concern.
• Support return-to-service walkthroughs and Manufacturing inspection-readiness walkthroughs as needed and per procedures.
• Ensure electronic and paper documentation requiring QA review complies with corporate and site procedures, cGMP regulations, and other industry guidelines.
• May support Quality review of manufacturing deviations.
• May support release of incoming or manufactured products.
• Perform routine QA floor support activities, including alarm review and logbook review.
• Perform other duties as assigned.

Benefits

• Wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings, subject to applicable plan terms and eligibility.
• Flexible Time Off (FTO) without a set accrual limit for eligible U.S.-based exempt employees, subject to manager approval.
• For non-exempt employees, RayzeBio employees, and employees in Puerto Rico: 160 hours of paid vacation annually for new hires, subject to manager approval, 11 paid company holidays, and 3 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 additional discretionary incentive cash and stock opportunities.

What This Job Offers

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