
Description
Senior Quality Control Analyst (Microbiology) – Contract
Location: Gaithersburg, MD (On-site)
Schedule: Monday–Friday, 8:00 AM – 5:00 PM (occasional weekends)
Duration: 3 months
Pay Rate: $47–$50 per hour
Start Date: ASAP About the Role
We are seeking a Senior Quality Control Analyst (Microbiology) to support microbiology programs focused on lentiviral vector and cell & gene therapy development. The ideal candidate will have hands-on experience in a cGMP microbiology quality control environment, strong technical acumen, and the ability to work independently with minimal supervision.
This role plays a key part in ensuring product quality and compliance with internal procedures and regulatory standards (ICH, CFR, etc.). Key Responsibilities
- Execute day-to-day microbiology testing and related activities with minimal supervision.
- Apply sound scientific and technical judgment to ensure accuracy and reliability of results.
- Conduct and write investigations, reports, and deviations independently or with limited assistance.
- Identify and support resolution of out-of-trend (OOT) and out-of-specification (OOS) events.
- Contribute to the improvement of existing procedures and development of new laboratory processes.
- Coordinate sample shipments, contract laboratory testing, and equipment maintenance.
- Maintain and track microbiological data and metrics for management review.
- Ensure compliance with all cGMP, internal, and regulatory guidelines.
- Bachelor's (B.S.) or Master's (M.S.) degree in Biotechnology, Biology, Chemistry, or a related field.
- 5+ years of hands-on experience in a cGMP microbiology QC laboratory within the biotech or pharmaceutical industry.
- Strong understanding of aseptic technique, product sample handling, and microorganism culture.
- Proven ability to write and support technical documentation, including SOPs, protocols, and investigations.
- Excellent attention to detail, organizational, and problem-solving skills.
- Strong communication abilities—both written and verbal—and experience collaborating with cross-functional teams.
- Proficiency with Microsoft Office applications (Excel, Word, PowerPoint, Outlook).
- Prior experience supporting cell and gene therapy programs or lentiviral vector manufacturing.
- Familiarity with ICH and CFR regulatory guidance.
- Demonstrated ability to manage multiple priorities in a fast-paced, highly regulated environment.
This role requires industry experience—candidates with academic or NIH backgrounds only will not be considered. Hands-on biotech or pharmaceutical experience is essential.
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