Microbiology Jobs at Glenmark Pharmaceuticals
Glenmark Pharmaceuticals is hiring a Microbiology Analyst for its manufacturing facility in Monroe, North Carolina. The candidate hired for Microbiology Jobs at Glenmark Pharmaceuticals should support the release of intermediates and finished pharmaceutical products by performing routine and non-routine microbiological testing, environmental monitoring, and sterility testing in accordance with cGMP/GLP regulations. The position is ideal for microbiology professionals with hands-on experience in aseptic techniques and pharmaceutical quality laboratories.
Job Details:
- Job Title: Microbiology Analyst
- Location: Monroe, NC, United States
- Employment Type: Full-Time
- Industry: Pharmaceuticals / Quality Control / Microbiology
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Work Authorization:
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No visa sponsorship available
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Applicants must be authorized to work in the U.S.
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- Experience Level: Entry to Mid-level (1–3 years)
- Work Environment: cGMP / FDA-regulated laboratory
About the Company:
Glenmark Pharmaceuticals is a global pharmaceutical company known for its innovation-driven approach to discovering New Chemical Entities (NCEs) and New Biological Entities (NBEs). With a strong presence in branded generics and APIs, Glenmark serves both regulated and semi-regulated markets worldwide. Its U.S. generics business continues to grow rapidly, supported by robust manufacturing, quality, and compliance systems.
Educational Requirements for the Microbiology Analyst Role:
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Minimum Qualification:
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BS in Microbiology, Biology, or equivalent
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Preferred Qualification:
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Degree in Microbiology
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Key Responsibilities:
- As a Microbiology Analyst, you should perform routine and non-routine microbiological testing of in-process, raw material, and finished products.
- Conduct environmental monitoring (viable and non-viable) in aseptic manufacturing areas.
- Perform sterility testing, Growth Promotion Testing, and Biological Indicator testing
- Count colony-forming units (CFU) on Petri plates
- Complete gown qualification to work in aseptic areas
- Perform routine sampling of WFI, Purified Water, Clean Compressed Air, and Nitrogen systems
- Support critical manufacturing process interventions
- Maintain accurate test records and daily sample logs
- Enter results into LIMS
- Maintain instrument usage, calibration, and maintenance logs
- Ensure laboratory documentation control (COAs, test instructions, records)
- Conduct and document OOS/OOL investigations
- Support method transfer, method validation, troubleshooting, and cross-validation in the Microbiology Analyst Role.
- Participate in supplier and contract laboratory audits
- Support IQ/OQ protocols and third-party equipment maintenance
- Perform statistical evaluation of manufacturing and inspection processes
- Maintain microbiology inventory and reduce wastage
- Prepare reagents, media, and materials under sterile conditions
- Establish effective relationships with contract laboratories
- Ensure all laboratory equipment is calibrated and compliant
Skills Required:
- Strong knowledge of cGMP and GLP regulations
- Hands-on experience with aseptic techniques
- Experience in pharmaceutical microbiology laboratories
- You must have proficiency in LIMS, Microsoft Word, and Excel for the Microbiology Analyst Role.
- Strong documentation and data integrity skills
- Ability to investigate deviations and support CAPA activities
- Good verbal and written communication skills
- Strong organizational and time management abilities
Benefits of Microbiology Jobs:
- Opportunity to work with a global pharmaceutical leader
- Exposure to FDA-regulated cGMP manufacturing environments
- Hands-on experience in aseptic processing and microbiology QC
- Skill development in sterility testing, EM, and regulatory compliance
- Career growth opportunities in Quality Control, Microbiology, and Validation
- Collaborative and compliance-focused work culture
