QC Microbiology Analyst II

Bimeda•Pomona, CA

3d•$33 - $37•Onsite

About The Position

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.

Requirements

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.

Responsibilities

Perform antibiotic microbial assays using USP <81> 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.