Senior QC Analytical, Cell Therapy - Validation & Data

Bristol-Myers Squibb Co; Summit (NJ); On-site; USD 56,000 - 68,000; Full time

Benefits offered by this job

Comprehensive benefits

Flexible time off

11 paid holidays

Job summary

Bristol Myers Squibb Co is seeking a Senior Specialist, QC Analytical, Cell Therapy in Summit, NJ. You will support QC testing for in-process, final product, and stability samples, perform method transfer/validation, data review, and document revisions, while driving deviations/investigations and continuous improvement.

The role emphasizes training and mentoring others, adherence to cGMP, and effective communication with cross-functional teams. The shift is Sunday to Wednesday, 1:30pm–11:30pm.

Qualifications

• Ability to understand, follow and apply Global Regulatory and cGMP requirements.
• Demonstrated technical writing skills.
• High problem-solving ability and logical thinking.

Responsibilities

• Perform method transfer/validation and routine QC testing of in-process, final product, and stability samples.
• Troubleshoot and solve problems with minimal guidance.
• Review GMP documentation and perform data verification/review.
• Revise documents, manage CAPA and deviations/investigations, drive continuous improvement.
• Train and mentor others on QC methods and procedures.
• Perform other duties as assigned.

Skills

GMP compliance

Technical writing

Problem solving

Communication

QC testing

Teamwork

Tools

LIMS

ELN

Data analysis software

Job description

Bristol Myers Squibb Co is seeking a Senior Specialist, QC Analytical, Cell Therapy in Summit, NJ. You will support QC testing for in-process, final product, and stability samples, perform method transfer/validation, data review, and document revisions, while driving deviations/investigations and continuous improvement.

The role emphasizes training and mentoring others, adherence to cGMP, and effective communication with cross-functional teams. The shift is Sunday to Wednesday, 1:30pm–11:30pm.