Senior QC Analytical Specialist for Cell Therapy

Bristol Myers Squibb; Summit (NJ); On-site; USD 56,000 - 69,000; Full time

Job summary

Bristol Myers Squibb in Summit, NJ, is seeking a Senior Specialist, QC Analytical, Cell Therapy to support in-process, final product, and stability testing. You will review data, troubleshoot methods, and assist with deviations, CAPA, and continuous improvement.

The role requires a Bachelor’s degree plus 4+ years in analytical QC in regulated environments; shift is Sunday to Wednesday, 1:30pm–11:30pm, with comprehensive benefits and growth opportunities.

Qualifications

• Understand, follow, interpret and apply Global Regulatory and cGMP requirements.
• Demonstrated technical writing skills.
• High problem-solving ability/mentality, technically adept and logical.
• Communicate effectively with peers and management about task status and needs.
• Work in a fast-paced team environment, meet deadlines, prioritize work.
• Advanced knowledge of LIMS, ELN and lab data analysis systems preferred.

Responsibilities

• Perform method transfer/validation and routine testing of in-process, final product, and stability samples.
• Anticipate and perform routine troubleshooting with minimal guidance.
• Perform data verification, data review and GMP documentation review.
• Perform document revision, project, CAPA and deviation/investigation tasks and continuous improvement.
• Train and mentor others on QC test methods, processes and procedures.
• Perform other tasks as assigned.

Skills

Regulatory compliance

Technical writing

Problem solving

Communication

Teamwork

LIMS/ELN knowledge

Education

Bachelor's degree

4+ years QC experience

Job description

Bristol Myers Squibb in Summit, NJ, is seeking a Senior Specialist, QC Analytical, Cell Therapy to support in-process, final product, and stability testing. You will review data, troubleshoot methods, and assist with deviations, CAPA, and continuous improvement.

The role requires a Bachelor’s degree plus 4+ years in analytical QC in regulated environments; shift is Sunday to Wednesday, 1:30pm–11:30pm, with comprehensive benefits and growth opportunities.