Quality Control — Microbiology Job Centennial area,Colorado USA,Healthcare

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 , , and , 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 clean rooms
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 Testing:

Coordinate sterility testing for CSPs using membrane filtration or direct inoculation
Monitor incubation and growth observations according to USP
Document results and escalation any abnormal findings per established protocols

Endotoxin Testing (USP ):

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
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, and calibration certificates
Ensure compliance with cGMPs and lab SOPs

SOP Management and Document Control:

Draft, revise, and review SOPs, protocols, and microbiological test methods
Ensure alignment with USP chapters, FDA guidance, and internal procedures
Support regular SOP review cycles and change control processes

Interdepartmental

Collaboration:

Partner with QA and Production on cleanroom control and contamination risk management
Participate in cross-functional meetings, audits, and projects
Provide microbiological input for risk assessments and change controls

Audit and Regulatory Support:

Prepare and present microbiology data during internal and external audits
Support regulatory inspections with required documentation
Maintain an audit-ready state through continuous compliance

Physical Demands:

Ability to stand for long periods of time during cleanroom monitoring or gowning activities
Fine motor skills to handle small lab tools, pipettes, swabs, and other microbiological…