Microbiologist

Microbiologist

Permanent | Tappan, NY | Monday–Friday, 12:00 p.m.–8:30 p.m.

About the Role

Join the Quality Control department and help ensure raw materials, supplies, and finished packaged products meet GMP requirements. The Microbiologist performs testing and analysis, maintains data integrity, and supports Operations and Manufacturing in the safe and effective release of finished products. Hands-on experience with USP , , and is required.

Responsibilities

• Perform routine microbiological testing of water, bulk pharmaceutical chemicals, drug products, and finished products.
• 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 data.
• Perform aseptic sampling to evaluate compressed air and cleaning and sanitization processes.
• Conduct basic microorganism identification and prepare media for microbiological testing.
• Aseptically sample raw materials and finished products for microbial testing.
• Process, review, and document microbiology results according to internal procedures, approved methods, and data-integrity principles.
• Review microbiology data in a timely manner and ensure ALCOA principles are followed.
• Write scientifically sound investigation reports, nonconformance evaluations, and root-cause investigations.
• Write and update SOPs to support regulatory compliance.
• Assist with laboratory equipment maintenance, calibration, and certification.
• Support LIMS and other microbiology-related projects.

Qualifications

• Bachelor’s degree in Biology, Microbiology, or a related science.
• 2–4 years of professional experience in pharmaceutical microbiology, or an equivalent combination of training and experience.
• Hands-on experience with USP Chapters , , and .
• Knowledge of cGMP and FDA requirements.
• Proficiency in traditional microbiology techniques, including Gram staining, streak plating, culture maintenance, and aseptic technique.