Sr. QC Specialist - Analytical - 177755

Piper Companies; Branchburg Township (NJ); In loco; USD 48.000 - 55.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical

Dental

Vision

401(k)

Sick Leave

Paid Holidays

Descrizione del lavoro

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, running flow cytometry and ELISA/MSD, and maintaining GDP-compliant documentation.

Competenze

• 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).

Mansioni

• 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.

Formazione

BSc in Molecular Biology

Strumenti

PCR

qPCR

ddPCR

Flow Cytometry

ELISA/MSD

Descrizione del lavoro

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 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: $35-40/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 10/12/2026 and will remain open for a minimum of 30 days from the posting date.

Keywords: QC Analyst, QC Analytical, Quality Control, Molecular Biology, PCR, qPCR, ddPCR, Flow Cytometry, ELISA, Cell Therapy, Biologics, Biotechnology, GMP, Product Release, Analytical Testing

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