Position Summary
The Microbiologist is responsible for executing and overseeing microbiological testing programs in a 503B outsourcing facility to ensure compliance with cGMP, USP <71>, <61>, <62>, <85>, <797>, and FDA requirements. This role ensures sterility assurance and environmental control of aseptic manufacturing operations.
Key ResponsibilitiesMicrobiological Testing
- Perform and/or oversee:
- Sterility testing (USP <71>)
- Bioburden testing (USP <61>/<62>)
- Bacterial endotoxin testing (USP <85>)
- Conduct method suitability testing
- Review and approve microbiology test results
Environmental Monitoring (EM)
- Execute EM program for:
- ISO 5, ISO 7 cleanrooms
- Viable air, surface, and personnel monitoring
- Trend EM data and identify adverse patterns
- Initiate investigations for excursions and OOS results
Aseptic Process Support
- Support media fills (aseptic process simulations)
- Perform growth promotion testing
- Manage incubation of EM plates and media
- Oversee biological indicator testing (autoclaves, depyrogenation where applicable)
Quality & Compliance
- Ensure compliance with:
- 21 CFR 211 (cGMP)
- USP microbiology chapters
- Write/review:
- SOPs
- Validation protocols/reports
- Deviations, CAPAs, and investigations
- Support FDA inspections, audits, and responses (483s)
Data & Trending
- Perform trend analysis on:
- Environmental monitoring
- Sterility failures
- Bioburden levels
- Provide risk assessments and recommendations
Qualifications
- Bachelor’s degree in:
- Microbiology, Biology, or related field (required)
- 2–5+ years experience in:
- Sterile manufacturing (503B highly preferred)
- Strong knowledge of:
- USP <71>, <85>, <61>, <62>
- Aseptic technique and contamination control
- cGMP regulations (21 CFR 210/211)
Core Competencies
- Strong analytical and investigation skills
- Deep understanding of aseptic processing risks
- High attention to detail and documentation accuracy
- Ability to operate in FDA inspection-ready environment
Additional Expectations
- Must maintain training and gowning qualifications
- Must support weekend/holiday testing as needed
- Must uphold quality-first mindset over production pressure
Pay: $25.00 - $30.00 per hour
Benefits:
- Dental insurance
- Health insurance
- Vision insurance
Work Location: In person
