What are the responsibilities and job description for the Quality Control Microbiologist position at United Pharma Technologies Inc?
Job Title: QC Microbiologist
Location: Boston, MA
Position Overview:
We are seeking a dedicated and experienced QC Microbiologist to join our Quality Control team in Boston, MA. This position will support cell and gene therapy manufacturing by performing critical microbiological testing in a GMP-regulated, aseptic environment. The ideal candidate will have strong expertise in aseptic techniques, microbiology, and quality systems, with hands-on experience in both QC Micro and QC Chemistry practices.
Key Responsibilities:
- Conduct routine and non-routine microbiological testing, including environmental monitoring, bioburden, endotoxin, and sterility testing on raw materials, in-process samples, and final products.
- Support cleanroom aseptic practices through environmental and personnel monitoring and aseptic process simulation (APS).
- Perform QC chemistry tests such as pH, conductivity, and appearance as needed to support product release.
- Ensure compliance with GMP, GLP, and FDA regulations, maintaining high standards of data integrity and documentation.
- Assist in method qualification and validation for microbiological assays in support of cell and gene therapy products.
- Participate in investigations, deviation reporting, CAPAs, and continuous improvement initiatives.
- Collaborate closely with Manufacturing, Quality Assurance, and Development teams to support timely and compliant product release.
Qualifications:
- Bachelor’s or Master’s degree in Microbiology, Biotechnology, Biology, or a related life sciences discipline.
- 2 years of hands-on experience in a QC Microbiology laboratory within a GMP-regulated environment.
- Working knowledge of aseptic technique, cleanroom behavior, and microbiological control.
- Experience with cell therapy, gene therapy, or other advanced biologics is strongly preferred.
- Familiarity with regulatory standards including USP, EP, FDA, and ICH guidelines.
- Excellent communication and organizational skills with strong attention to detail.
