Microbiology Jobs at Glenmark Pharmaceuticals USA
Step into the world of pharmaceutical quality and innovation with a high-demand Microbiology Job at Glenmark Pharmaceuticals. This Microbiology Analyst role in the USA is a fantastic opportunity for candidates seeking Jobs in USA and a stable job opportunity for life science graduates. If you have a passion for microbiology, laboratory testing, and regulatory compliance, this role offers hands-on experience in a globally recognized pharmaceutical company.
About Glenmark Pharmaceuticals
Glenmark Pharmaceuticals is a globally recognized pharmaceutical company committed to providing high-quality and innovative healthcare solutions. With a strong presence in the life sciences sector, we focus on research and development to advance pharmaceutical and therapeutic technologies.
Job Details:
- Job Title: Microbiology Analyst
- Location: Monroe, North Carolina, United States
- Company: Glenmark Pharmaceuticals
Important: No visa sponsorship available — applicants must already be authorized to work in the U.S.
Microbiology Analyst Position Overview
The Microbiology Analyst at Glenmark Pharmaceuticals plays a key role in ensuring the quality and safety of pharmaceutical products by performing microbiological testing on raw materials, in-process samples, and finished products. This role supports product release and ensures compliance with regulatory standards such as U.S. Food and Drug Administration guidelines and Current Good Manufacturing Practice (cGMP).
Key Responsibilities
Microbiological Testing & Monitoring
- Perform routine and non-routine microbiological tests on raw materials, in-process, and finished products.
- Conduct environmental monitoring (EM) for aseptic manufacturing areas.
- Perform sterility testing, growth promotion testing, and biological indicator testing.
- Count colony-forming units (CFU) on agar plates.
Sampling & Utilities Monitoring
- Collect and test samples from critical utilities such as Water-for-Injection (WFI), Purified Water, Compressed Air, and Nitrogen systems.
Aseptic Operations
- Complete gown qualification to work in sterile/cleanroom environments.
- Perform critical interventions in aseptic manufacturing areas.
Laboratory Operations
- Prepare reagents, media, and equipment under sterile conditions (e.g., HEPA hoods).
- Maintain sample logs and ensure timely testing and tracking.
- Enter results into Laboratory Information Management Systems (LIMS).
- Maintain instrument usage, calibration logs, and perform routine maintenance.
Documentation & Compliance
- Maintain accurate and complete test records.
- Ensure all laboratory documentation and databases are up to date.
- Support investigations for out-of-specification (OOS/OOL) results.
- Ensure compliance with Good Laboratory Practice (GLP) and cGMP standards.
Quality & Continuous Improvement
- Assist in method transfer, validation, and troubleshooting.
- Support audits (internal, supplier, and contract labs).
- Perform statistical analysis of manufacturing and inspection processes.
- Help train QC staff and maintain lab efficiency.
Inventory & Coordination
- Monitor and report lab supply needs to minimize waste.
- Coordinate with contract labs and vendors.
Education
- Bachelor’s degree in Microbiology, Biology, or related field
- Microbiology specialization preferred
Experience Required for Microbiology Job
- 1–3 years in a Current Good Manufacturing Practice (cGMP) or Good Laboratory Practice (GLP) lab
- Experience in pharmaceutical or U.S. Food and Drug Administration-regulated environments preferred
- Hands-on microbiology lab experience (aseptic techniques required)
Skills & Competencies
- Strong understanding of cGMP regulations in lab settings
- Good documentation and record-keeping skills
- Proficiency in Microsoft Office (Word, Excel)
- Strong communication (written & verbal)
- Excellent organizational and time management skills
