QC Micro Consultant
Branchburg, New Jersey
Job Id:
161341
Job Category:
Job Location:
Branchburg, New Jersey
Security Clearance:
No Clearance
Business Unit:
Piper Companies
Division:
Piper Clinical Solutions
Position Owner:
Karen Pallone
Piper Companies is seeking a QC Specialist, Micro to join a leading biotechnology company developing next-generation allogeneic cell therapies for oncology.
This is an onsite position in Branchburg, NJ and a 6 month term contract assignment with potential for conversion.
Responsibilities:
- Perform endotoxin testing (e.g., LAL, kinetic chromogenic/turbidimetric methods) in accordance with GMP requirements
- Execute sterility testing (USP <71>) and support investigations related to sterility failures or excursions
- Conduct and/or support rapid microbiological testing methods, as applicable
- Provide Environmental Monitoring (EM) support, including viable and non-viable monitoring of classified cleanrooms
- Review, document, and trend microbiological data; identify deviations and support root cause investigations
- Support method troubleshooting, assay qualification/validation, and continuous improvement initiatives
- Ensure all testing and documentation complies with cGMPs, USP, and internal SOPs
- Collaborate cross-functionally with Manufacturing, QA, and other QC teams during routine operations and audits
- Assist with audit readiness and regulatory inspections as needed
Qualifications:
- Bachelor’s degree in Microbiology, Biology, or a related scientific discipline
- 3–7+ years of QC Microbiology experience in a GMP pharmaceutical, biotech, or cell/gene therapy environment
- Hands-on experience with:
- Endotoxin testing
- Sterility testing
- Rapid microbial methods
- Environmental Monitoring programs
- Strong knowledge of cGMPs and relevant USP chapters (e.g., <61>, <62>, <71>, <85>)
- Experience documenting and investigating microbiological deviations and excursions
- Ability to work independently in a fast-paced, regulated environment
Compensation:
- Pay Rate: $85,000-$95,000 on a W2 contract rate; depending on experience
- Benefits Available: Medical, Dental, Vision, Sick Leave as required by law
This job opens for applications on 3/6/2026. Applications for this job will be accepted for at least 30 days from the posting date.
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