Microbiologist- Permanent Position, Edison, NJ
Responsible for performing routine and advanced microbiological testing in a cGMP-compliant FDA-regulated laboratory. This role supports testing for pharmaceutical, OTC, cosmetic, dietary supplement, and botanical products.
Responsibilities
- Perform routine microbiological testing including :
- USP Microbial Enumeration Tests
- USP Tests for Specified Microorganisms
- USP Antimicrobial Effectiveness Testing
- Bioburden, endotoxin, water, and microbial ID testing
- Support and execute growth promotion testing and media preparation
- Maintain microbial cultures and manage lab inventory and equipment (incubators, refrigerators, freezers)
- Analyze, document, and interpret test results in accordance with FDA cGMP and Good Documentation Practices (GDP)
- Review peer data for accuracy, integrity, and compliance with protocols and regulatory standards. Occasionally support weekend or evening testing as business needs require
Qualifications
Bachelor’s degree in microbiology, Biological Sciences, or a related scientific field2–3 years of hands-on microbiology lab experience in a regulated environmentRequired Skills
Proficient in aseptic techniques and routine microbiological assaysWorking knowledge of : USP, Bioburden and endotoxin testing, Growth promotion and compendial testingFamiliarity with FDA cGMP, GDP, and laboratory quality proceduresPreferred Skills
Antibiotic potency testingSterility testingAdvanced compendial methodsExposure to environmental monitoring programs