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Manufacturing
Quality Control Analyst
Branchburg, NJ
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Analytical to support an innovative and growing cell therapy organization in Branchburg, NJ . The Sr. QC Specialist will perform analytical testing in a cGMP Quality Control laboratory, supporting product release, method execution, and quality operations through molecular and cell-based assays. Responsibilities of the QC Specialist
Analytical:
Perform QC analytical testing in a cGMP laboratory to support product release and stability testing
Execute molecular assays including PCR, qPCR, and/or ddPCR, along with other nucleic acid-based testing
Perform analytical assays such as flow cytometry, ELISA/MSD, cell viability, cell enumeration, and characterization testing
Analyze and trend laboratory data while maintaining accurate documentation in accordance with cGMP and Good Documentation Practices (GDP)
Support laboratory investigations, deviations, OOS/OOT events, and CAPA activities as needed
Author and revise SOPs, technical reports, and other controlled documentation
Operate, maintain, and troubleshoot analytical laboratory instrumentation Qualifications of the QC Specialist
Analytical:
Bachelor's degree in Molecular Biology, Biology, Biotechnology, Biochemistry, or a related scientific discipline
3+ years of QC analytical experience in a cGMP biotechnology, biologics, cell therapy, or pharmaceutical environment
Hands-on experience with PCR, qPCR, ddPCR, or other molecular assay platforms
Experience performing QC analytical testing for product release in a GMP laboratory
Exposure to DNA/RNA sequencing, ELISA/MSD, or flow cytometry is highly preferred
Strong understanding of cGMP regulations and Good Documentation Practices (GDP) Compensation for the QC Specialist
Analytical:
Pay Rate:
$40-45/hr.
Contract-to-Hire
Comprehensive Benefits:
Medical, Dental, Vision, 401(k), Sick Leave (as required by law), and
Paid Holidays Application Period:
This position opens for applications on 7/21/2026 and will remain open for a minimum of 30 days from the posting date.