Quality Control Microbiology Specialist (GMP/USP)

Vpicompounding; Centennial (CO); On-site; USD 36,000 - 43,000; Full time

Benefits offered by this job

Health insurance

401(k) plan with employer match

Paid holidays and PTO

Tuition reimbursement

Transit/eco pass

Job summary

VPI Compounding Pharmacy seeks a Quality Control — Microbiology professional to oversee environmental monitoring, sterility testing, and microbial identification to ensure GMP compliance. You will manage sampling, testing, and trend analysis to protect the microbiological integrity of CSPs.

The role requires a Bachelor’s in Microbiology with at least 2 years’ regulated pharma/biotech experience and familiarity with USP chapters.

Qualifications

• Bachelor’s degree in Microbiology, Biology, or related field.
• Minimum 2 years of microbiological testing in regulated pharma/biotech/compounding environment.
• Familiarity with USP chapters: <795> <797> <71> <85> <1116>.
• Experience with environmental monitoring, bioburden testing, and sterility testing protocols.

Responsibilities

• Environmental Monitoring: perform EM of ISO-classified cleanrooms and sampling.
• Microbiological Testing of Utilities and Materials: test water systems, surfaces, and personnel for contamination.
• Sterility Assurance and USP <71> testing: coordinate sterility testing for CSPs and monitor incubation.
• Endotoxin Testing (USP <85>): oversee BET using LAL methods and ensure methods meet requirements.
• Microbial Identification and Trending: identify organisms and track cleanroom isolates and contamination data.
• OOS and Excursion Investigations: lead investigations and perform root-cause analysis.
• Aseptic Technique and Gowning Qualification Support: observe practices and support training.
• Laboratory Equipment Maintenance and Qualification: maintain EM and microbiology equipment and logs.
• SOP Management and Document Control: draft and revise SOPs in line with USP/FDA guidance.
• Interdepartmental Collaboration: partner with QA and Production on contamination risk management.
• Audit and Regulatory Support: prepare microbiology data for audits and inspections.

Skills

Environmental Monitoring

Sterility Testing

Bioburden Testing

Aseptic Technique

Data Analysis

Education

Bachelor's Degree in Microbiology

Tools

LIMS

Google Suite

Job description

VPI Compounding Pharmacy seeks a Quality Control — Microbiology professional to oversee environmental monitoring, sterility testing, and microbial identification to ensure GMP compliance. You will manage sampling, testing, and trend analysis to protect the microbiological integrity of CSPs.

The role requires a Bachelor’s in Microbiology with at least 2 years’ regulated pharma/biotech experience and familiarity with USP chapters.