QC Microbiology Analyst II
Bimeda
Job Title: QC Microbiology Analyst II Location: Pomona, CA (In-office) Position Type: Full-time Vacancy Status: This position is vacant AI Disclosure in Hiring: We use artificial intelligence to screen, assess and select applicants Purpose of the Position/ Role Summary The QC Microbiology Analyst II is responsible for performing a broad range of microbiological and environmental monitoring activities to support product release, stability programs, raw material qualification, and manufacturing operations. This role requires a skilled analyst who can integrate quickly into laboratory operations, provide technical guidance to peers, and uphold Bimeda's standards for quality, safety, and compliance. Key Role Specific Requirements Microbiological Testing
- Perform antibiotic microbial assays using USP methods, including cylinder plate techniques.
- Conduct Microbial Limit Testing (TAMC, TYMC, objectionable organisms).
- Execute microbiological testing for routine analysis, stability protocols, and raw material qualification.
- Perform sampling and bioburden testing of in-process materials, Purified Water, and City Water.
- Prepare and validate microbiological media; ensure growth promotion testing is completed prior to use.
- Maintain media inventory and monitor temperatures of incubators and refrigerators.
- Prepare, sterilize, and sanitize equipment and facilities used in microbiological testing.
- Perform routine EM of surfaces and air in classified and non-classified areas.
- Conduct compressed gas sampling and testing.
- Perform microbial isolation techniques, gram stains, and support microbial identification processes.
- Track and trend EM data, including microbial identification results, to support product release.
- Coordinate EM sampling schedules with manufacturing teams.
- Support EM process validation and equipment qualification activities.
- Review and document test data following Good Documentation Practices (GDP).
- Maintain laboratory areas in a cGMP-compliant state and follow EHS and 5S guidelines.
- Ensure data integrity and compliance with SOPs, FDA, GLP, QSR, and cGMP regulations.
- Revise SOPs and assist in protocol creation and editing.
- Complete assigned CAPAs and support deviation investigations using problem-solving tools.
- Assist with execution of validations for lab equipment, methods, or facility projects.
- Participate in internal and external audits; act as subject matter expert and support gowning training.
- Order and maintain laboratory supplies relevant to microbiological and EM activities.
- Promote a culture of quality and cross-functional collaboration.
- Flexibility to work off-hours and weekends as required.
- Physical demands: Walking, standing, occasional lifting (up to 50 pounds).
- May require work outside regular hours or weekends.
- BS in Microbiology, Biochemistry, or related discipline.
- Minimum 3 years of experience in the pharmaceutical or related industry.
- Minimum 1 year of EM experience in pharmaceutical/biotech industry; or Associate degree with 3 years of EM experience.
- Familiarity with cGMP, GLP, GDP, and FDA guidance documents.
- Experience with deviations, CAPAs, change controls, and root cause analysis.
- Ability to train others and encourage teamwork.
- Working knowledge of SOPs, EHS requirements, and laboratory systems.
- Experience with electronic systems such as LIMS.
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