Cell Therapy Microbiology QC Specialist (cGMP)

Piper Companies

Branchburg Township (NJ)

On-site

USD 55,000 - 58,000

Full time

27 hours ago
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Benefits offered by this job

Medical benefits
Dental benefits
Vision benefits
401K
Paid holidays

Job summary

Piper Companies is seeking a QC Specialist – Microbiology to support a cutting-edge cell therapy organization in Branchburg, NJ. This role performs microbiological testing in a cGMP laboratory environment, supporting manufacturing and quality operations.

Responsibilities include endotoxin and sterility testing, environmental monitoring, data review, and documentation in compliance with SOPs and regulatory requirements. A BS/MS in a related field is preferred, with 4+ years’ experience.

Qualifications

  • 4+ years of experience in a cGMP microbiology or QC laboratory.
  • Hands-on experience with BET (endotoxin), sterility testing, and rapid microbial testing.
  • Exposure to or experience supporting environmental monitoring (EM) programs.
  • Strong understanding of aseptic technique and contamination control.
  • B.S. or M.S. in Microbiology, Biology, Biotechnology, or a related scientific discipline.

Responsibilities

  • Perform microbiological testing including BET (endotoxin), sterility testing, and rapid microbial methods.
  • Support environmental monitoring (EM) activities as needed, including sampling and documentation.
  • Execute testing in compliance with cGMP, SOPs, and regulatory requirements.
  • Document test results, review data, and complete reports in accordance with cGMP standards.
  • Assist with troubleshooting, investigations, and method validations/transfers.
  • Draft, review, and update SOPs, protocols, and technical documentation.
  • Maintain laboratory instruments and ensure proper calibration and cleanliness.

Skills

cGMP
Endotoxin testing
Sterility testing
Environmental Monitoring
Aseptic Technique

Education

B.S./M.S. in Microbiology/Biology/Biotechnology

Job description

Piper Companies is seeking a QC Specialist – Microbiology to support a cutting-edge cell therapy organization in Branchburg, NJ. This role performs microbiological testing in a cGMP laboratory environment, supporting manufacturing and quality operations.

Responsibilities include endotoxin and sterility testing, environmental monitoring, data review, and documentation in compliance with SOPs and regulatory requirements. A BS/MS in a related field is preferred, with 4+ years’ experience.

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