QC Microbiology Analyst – Environmental Monitoring

Glenmark Pharmaceuticals; Monroe (NC); On-site; USD 42,000 - 54,000; Full time

Job summary

Glenmark Pharmaceuticals Inc., USA invites applications for an entry-level QC Microbiology Analyst I in Monroe. The role supports routine microbiological sampling, environmental monitoring, and GMP-compliant testing to ensure product quality in a fast-paced, FDA-regulated pharmaceutical environment.

The position requires a Bachelor’s degree in Microbiology, Biology, or related life sciences and 0–2 years of related experience.

Qualifications

• A Bachelor’s degree in Microbiology, Biology, or related life science field.
• 0–2 years of related experience preferred.
• Understanding of aseptic technique and microbiological test methods.
• Familiarity with regulatory guidelines (e.g., 21 CFR Part 11, USP).

Responsibilities

• Models the principles and behaviors of Glenmark and ensures personnel follow the company code of conduct.
• Participate in projects, assignments, and complete presentations within timelines and budgets.
• Communicate progress, status, and roadblocks as required.
• Ability to perform routine sampling of utilities and EM monitoring.
• Train on routine testing of samples submitted to the laboratory.
• Participates in cleaning, inventory, and maintenance tasks in the lab.
• Accounts for inventory of QC department laboratory supplies.
• Ensures laboratory equipment is in compliance with procedures and GLP requirements prior to use.
• Troubleshoots laboratory issues related to all instrumentation and recommends corrective actions.
• Performs GMP review of test data to ensure results meet specifications.
• Train and perform on sampling of utilities.
• Train on microbial testing of routine microbiology samples of water systems.
• Conduct environmental monitoring of cleanrooms and controlled areas.
• Prepare and maintain microbial cultures and media.
• Train on media qualifications and microbial identifications.
• Maintain current knowledge of regulatory and industry standards, trends and advancements.
• Ensure compliance to systems and procedures in the EM/Microbiology lab and cleanroom areas.
• Support Continuous Improvement by updating SOPs, WIs, and OJTs.
• Ensure Quality Systems are compliant with cGMPs and regulations.
• Assist in changes at the site and in collecting EMPQ reports.
• Assist in self-audits of Microbiology and EM areas.
• Collaborate with other departments to meet established procedures and regulations.
• Communicate with management about supply variances and procurement.
• Track laboratory supply expenditures and usage and coordinate with suppliers.

Skills

Aseptic technique

Organizational skills

Written communication

Interpersonal skills

Regulatory awareness

SOPs

Analytical thinking

Problem solving

Safety awareness

Gowning and cleanroom

Education

Bachelor’s degree in Microbiology/Biology or related life science

Job description

Glenmark Pharmaceuticals Inc., USA invites applications for an entry-level QC Microbiology Analyst I in Monroe. The role supports routine microbiological sampling, environmental monitoring, and GMP-compliant testing to ensure product quality in a fast-paced, FDA-regulated pharmaceutical environment.

The position requires a Bachelor’s degree in Microbiology, Biology, or related life sciences and 0–2 years of related experience.