Senior QC Analyst – Analytical (Cell Therapy, GMP)

ZP Group; Branchburg Township (NJ); On-site; USD 73,000 - 83,000; Full time

Benefits offered by this job

Medical, Dental, Vision Insurance

401(k)

Sick Leave

Paid Holidays

Job summary

Piper Companies is seeking a Sr. QC Specialist – Analytical to support an innovative 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 include executing PCR/qPCR/ddPCR and other nucleic acid tests, flow cytometry and ELISA/MSD, documenting results per cGMPGDP, investigating deviations,

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).

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 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.

Skills

PCR/qPCR/ddPCR

Flow cytometry

ELISA/MSD

Education

Bachelor's degree in Molecular Biology or related field

Tools

GMP laboratory equipment

Job description

Piper Companies is seeking a Sr. QC Specialist – Analytical to support an innovative 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 include executing PCR/qPCR/ddPCR and other nucleic acid tests, flow cytometry and ELISA/MSD, documenting results per cGMPGDP, investigating deviations,