QC Microbiology Analyst II

About the role

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.

Responsibilities

• 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.
• Cook up and 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.
• Absorb and execute 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.

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.

Qualifications

• 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.

Skills

• Strong analytical skills.
• Excellent communication and documentation skills.
• Ability to work independently and as part of a team.
• Proficient in laboratory equipment and procedures.
• Knowledge of regulatory requirements and compliance.

Benefits

• Health Insurance (medical, dental, vision)
• 401(k) plan for retirement savings
• Paid time off (vacation, sick leave, holidays)
• Life insurance
• Employee assistance program

Pay

Competitive salary based on experience and qualifications.

Schedule

Full-time position with flexible working hours to accommodate warehouse and production environments.

About Bimeda

Bimeda is a leading global innovator, manufacturer and marketer of veterinary pharmaceuticals and animal health products. With over half a century's experience, Bimeda provides science-driven solutions to optimize the health, wellbeing, and productivity of the world's animals. Bimeda's global innovation program sees six state-of-the-art R&D centers across four continents collaborate on an enviable product development pipeline which anticipates the ever-evolving needs of the animal health industry. Bimeda's nine manufacturing facilities across seven countries allow the company to manufacture a broad range of preventative, curative, and nutritional products including sterile injectables, vaccinations, nutritional boluses, feed additives, tablets, water-soluble powders, pastes, and non-sterile liquids. Globally, Bimeda focuses on the development, manufacture, and commercialization of quality Bimeda-branded products while also being the partner of choice for contract manufacturing and R&D services for prominent companies within the animal health industry.

What We Offer

• Health Insurance (medical, dental, vision)
• 401(k) plan for retirement savings
• Paid time off (vacation, sick leave, holidays)
• Life insurance
• Employee assistance program

Equal Opportunity Employer

We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), sexual orientation, gender identity or expression, age, national origin, ancestry, citizenship, physical or mental disability, medical condition, genetic information, marital status, military or veteran status, or any other basis protected by applicable federal, state, or local law.