Quality Control — Microbiology

Quality Control — Microbiology
Department: Quality
Location: Centennial, CO, 80112
Employment Type: Full-Time.
Compensation:$26-$31 per hour
Job Summary
The Microbiologist will be responsible for overseeing environmental monitoring, sterility testing, and microbial identification processes to ensure compliance with USP <795>, <797>, and <800>, as well as FDA and state board regulations. This role plays a critical part in maintaining aseptic conditions and ensuring the microbiological integrity of compounded sterile preparations.
Key Responsibilities
Environmental Monitoring:
Perform routine and non-routine and non-viable EM of ISO-classified cleanrooms
Conduct active air, passive air, surface, and personal sampling during and after operations
Analyze data trends and ensure results are within facility-specific alert and action levels
Ensure proper sampling coverage of critical and non-critical zones.
Microbiological Testing of Utilities and Materials:
Test purified water systems, surfaces, and personnel for microbial contamination
Conduct bioburden testing of raw materials and components prior to compounding
Maintain sample traceability and data integrity from collection through result reporting
Sterility Assurance and USP <71> Testing:
Coordinate sterility testing for CSPs using membrane filtration or direct inoculation
Monitor incubation and growth observations according to USP <71>
Document results and escalate any abnormal findings per established protocols
Endotoxin Testing (USP <85>):
Oversee bacterial endotoxin testing (BET) using LAL methods (gel-clot, chromogenic, turbidimetric)
Ensure test methods meet compendial and product-specific requirements
Investigate test failures and assess impact on product quality and safety.
Microbial Identification and Trending:
Identify recovered organisms using Gram staining and advanced ID tools
Track trends in cleanroom isolates and product contamination data
Prepare monthly and quarterly microbiological trending reports (Data gave me this frequency - can change to reflect our needs - or leave as is)
OOS and Excursion Investigations:
Lead microbiology-related investigations for out-of-specification results or EM excursions
Perform root cause analysis and implement CAPs in collaboration with QA
Ensure accurate, complete, and timely investigation documentation
Aseptic Technique and Gowning Qualification Support:
Observe and evaluate aseptic practices during media fills and daily operations
Assist with training, qualification, and periodic requalification of cleanroom personnel
Review gowning footage and aseptic practices for compliance with SOPs
Laboratory Equipment Maintenance and Qualification:
Oversee calibration and maintenance of EM and microbiology lab equipment (e.g., air sampler, endotoxin readers)
Maintain equipment logs, service records, an

Employment type
Full-Time

Work arrangement
No