Sr. QC Specialist - Analytical

About the role

Piper Companies is seeking a Sr. QC Specialist – 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

• 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

• 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)

Benefits

• Medical
• Dental
• Vision
• 401(k)
• Sick Leave (as required by law)
• Paid Holidays

Pay

Pay Rate: $35-40/hr. Contract-to-Hire