Field QA Specialist: GMP Compliance & RTS Readiness

Regulatory Jobs; Massachusetts; Presencial; USD 90.000 - 108.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Comprehensive benefits

Flexible Time Off

Holidays

Descripción de la vacante

Bristol Myers Squibb is seeking a Senior Field QA Specialist to maintain quality oversight and GMP compliance in day-to-day manufacturing operations at the Devens, MA site.

Responsibilities include reviewing MBRs, real-time on-the-floor exception reviews, GMP area walkthroughs, and RTS walkthrough support to ensure areas and equipment are ready for production. The role collaborates across Manufacturing Operations and other QA functions.

Formación

• Bachelor's degree in science, engineering, biochemistry or related discipline.
• 4 years of Quality Assurance experience within the pharmaceutical or medical device industry.
• Batch record review experience.

Responsabilidades

• Quality floor support of complex manufacturing activities.
• Performs manufacturing batch production record review in support of product release in accordance with specifications and SOPs.
• Perform walkthroughs of GMP areas documenting observations and areas of concern.
• Perform training on routine facility Quality tasks for new team members.
• Supports return to service walkthroughs and Manufacturing inspection readiness walkthroughs per procedures as needed.
• Ensures all electronic and paper documentation requiring QA review complies with corporate/site procedures, cGMP, and guidelines.

Conocimientos

Biotech manufacturing

Quality Assurance

cGMP knowledge

Batch records

DeltaV

Cross-functional collaboration

Educación

BS in science/engineering

Herramientas

DeltaV software

Descripción del empleo

Bristol Myers Squibb is seeking a Senior Field QA Specialist to maintain quality oversight and GMP compliance in day-to-day manufacturing operations at the Devens, MA site.

Responsibilities include reviewing MBRs, real-time on-the-floor exception reviews, GMP area walkthroughs, and RTS walkthrough support to ensure areas and equipment are ready for production. The role collaborates across Manufacturing Operations and other QA functions.