QC Microbiology Analyst II

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 Bimedas standards for quality safety and compliance.

Key Role Specific Requirements

Microbiological Testing
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.

Environmental Monitoring
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.

Quality & Compliance
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.

Additional Notes

Working conditions: warehouse and production environments. Exposure to noise chemicals and machinery. PPE

required in certain areas.
Physical demands: Walking standing occasional lifting (up to 50 pounds).
May require work outside regular hours or weekends.

Please note that this job description is not exhaustive and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.

Competencies Required for the Role

INTEGRITY/PERSONAL CREDIBILITY Demonstrated ability and concern that one be perceived as responsible reliable and trustworthy.
FOSTERING COLLABORATION/TEAMWORK - is the ability to work jointly with others or together especially in an intellectual endeavor; the ability and desire to work cooperatively with others on a team; as a team leader the ability to demonstrate interest skill and success in getting groups to learn to work together. Builds partnerships for global performance. Respects others.
INITIATIVE - Identifying what needs to be done and doing it before being asked or before the situation requires it.
PLANNING is the process of thinking about and organizing the activities required to achieve a desired goal.
THOROUGHNESS/DETAIL ORIENTED Ensuring that ones own and others work and information are complete and accurate; carefully preparing for meetings and presentations following up with others to ensure that agreements and commitments have been fulfilled.

Other Requirements

Required:
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.

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

About Bimeda

Bimeda is a leading global innovator manufacturer and marketer of veterinary pharmaceuticals and animal health products and has over half a centurys experience in providing science-driven solutions to optimize the health wellbeing and productivity of the worlds animals.

Bimedas 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.

Bimedas 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 the company 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.

Bimeda is an 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.

We value diverse perspectives and encourage applications from people of all backgrounds experiences and abilities. If you need a reasonable accommodation to participate in the application or interview process please contact us at

Required Experience:

Senior IC