GMP QC Materials & Lab Documentation Specialist

Bristol Myers Squibb; Summit (NJ); Hybrid; USD 35,000 - 40,000; Full time

Job summary

Bristol Myer-Squibb in Summit, NJ seeks a Quality Control Raw Materials and Lab Support Specialist for a 12-month contract. Hybrid (50% onsite) with standard M-F hours, supporting CAR T manufacturing QC activities and GMP documentation. Requires 4+ years in a GxP environment and proven GMP writing experience.

Role involves deviations, change controls, investigations, CAPA development, and collaboration with internal teams. Bachelors in Science required; pharma experience essential.

Qualifications

• Pharma/Biotech or Regulated Health Industry experience in GxP environment.
• Proven experience writing GMP documents per GDPs.
• Ability to deliver high-volume, high-quality documentation.

Responsibilities

• Author and revise GMP documents and test execution documents.
• Manage GMP document development through document management systems.
• Support deviations, change controls, quality events, and investigations.
• Conduct thorough investigations using root-cause tools (OOS, OOT, deviations).
• Perform GEMBA walks with stakeholders to identify process improvements.
• Identify CAPAs and develop CAPA plans with effectiveness checks.
• Support change management documentation and impact assessments.
• Assist QC during audits and site inspections and report quality metrics.

Skills

Technical writing

GxP compliance

Attention to detail

Cross-functional collaboration

Change management

Root cause analysis

GMP/GDP knowledge

Communication

Adaptability

Education

Bachelor's degree in Science

Advanced degree preferred

Tools

TrackWise

Veeva

Microsoft Office

Job description

Bristol Myer-Squibb in Summit, NJ seeks a Quality Control Raw Materials and Lab Support Specialist for a 12-month contract. Hybrid (50% onsite) with standard M-F hours, supporting CAR T manufacturing QC activities and GMP documentation. Requires 4+ years in a GxP environment and proven GMP writing experience.

Role involves deviations, change controls, investigations, CAPA development, and collaboration with internal teams. Bachelors in Science required; pharma experience essential.