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Sr. QC Specialist - Analytical
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Based on New Jersey data
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What they do
A Quality Control Analyst, in the biotech and medical device industries, works in laboratories performing biological, microbiological, and chemical tests on products and materials. Responsible for calibrating equipment, inspecting products, processing and testing materials, and reporting results. May work in other production environments to monitor and improve quality and efficiency in production systems and products.
$68,618 / year median in New Jersey
-15% projected decline
Job Description
- 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