Microbiologist- Permanent Position
Location: Tappan, NY
Schedule: Monday–Friday, 12:00 p.m.–8:30 p.m.
Position Overview
The Microbiologist is part of the Quality Control department, which evaluates raw materials, supplies, and finished packaged products for compliance with GMP. This role performs microbiological testing and analysis, maintains data integrity, and supports Operations and Manufacturing in the safe and effective release of finished products.
Candidates must have hands-on experience with USP , , and microbiological testing.
Key Responsibilities
Microbiological Testing and Analysis
- Perform routine microbiological testing of water, bulk pharmaceutical chemicals, drug products, and finished products.
- Assess results in accordance with applicable test methods, procedures, and work instructions.
- Conduct method-suitability testing on finished products using traditional methods; document and report results.
- Collect and test water, environmental air, and surface samples; analyze and trend the resulting data.
- Perform aseptic sampling to evaluate compressed air and cleaning and sanitization processes. Conduct basic microorganism identification.
- Prepare microbiological media and aseptically sample raw materials and finished products for microbial testing.
- Prepare samples for shipment to external contract laboratories and coordinate with third-party labs to ensure specifications and results are properly provided and processed.
Quality, Documentation, and Data Integrity
- Process, review, and document microbiology results in accordance with internal procedures, methods, and data integrity principles.
- Review data generated by microbiologists in a timely manner and ensure ALCOA principles are followed.
- Write scientifically sound microbiology investigation reports, nonconformance evaluations, and root-cause investigations.
- Write and update SOPs to maintain compliance with regulatory standards.
- Ensure laboratory activities meet cGMP, cleanliness, and data integrity requirements.
Equipment and Laboratory Support
- Assist with laboratory equipment maintenance, calibration, and certification.
- Support LIMS and other microbiology-related projects.
Education
- Bachelor’s degree in Biology, Microbiology, or a related science from an accredited college or university.
Required Experience and Knowledge
- Two to four years of professional experience in a pharmaceutical microbiology environment, or an equivalent combination of training and experience.
- Experience with USP Chapters , , and .
- Knowledge of current Good Manufacturing Practices (cGMP) and FDA requirements.
- Proficiency in traditional microbiology techniques, including Gram staining, streak plating, culture maintenance, and aseptic technique.
- Ability to document results accurately and prepare clear technical reports.
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