Senior QC Analyst – Analytical Methods

Regulatory Jobs; Summit (NJ); On-site; USD 56,000 - 69,000; Full time

Job summary

Bristol Myers Squibb is seeking a Senior QC Specialist to perform routine testing of in-process, final product, and stability samples at the Summit, NJ facility. The role supports data review for general and complex methods to ensure timely drug product release.

Responsibilities include method transfer/validation, troubleshooting, documentation review, CAPA and deviation handling, plus mentoring QC staff. Shift: Wed-Sat 1:30pm-11:30pm.

Qualifications

• Bachelor’s degree or equivalent required, preferably in Science; advanced degree preferred.
• 4+ years of relevant analytical testing or QC experience in a regulated environment.
• Experience in cell and molecular biology techniques (cell-based assays, flow cytometry, qPCR, ELISA, aseptic technique).

Responsibilities

• Perform method transfer/validation and routine testing of in-process, final product, and stability samples.
• Troubleshoot and solve problems with minimal guidance.
• Review GMP documentation and data verification.
• Handle CAPA, deviations, and continuous improvement tasks.
• Train and mentor others on QC test methods.
• Perform other tasks as assigned.

Skills

Cell & molecular biology

Global regulatory & cGMP

Technical writing

Problem solving

Communication

Cross-functional collaboration

Fast-paced teamwork

LIMS/ELN/data systems

Education

Bachelor’s degree or equivalent

Advanced degree preferred

Tools

LIMS

ELN

Laboratory data systems

Job description

Bristol Myers Squibb is seeking a Senior QC Specialist to perform routine testing of in-process, final product, and stability samples at the Summit, NJ facility. The role supports data review for general and complex methods to ensure timely drug product release.

Responsibilities include method transfer/validation, troubleshooting, documentation review, CAPA and deviation handling, plus mentoring QC staff. Shift: Wed-Sat 1:30pm-11:30pm.