QC Analyst (Environmental Monitoring)

Job Responsibilities:

• Perform environmental monitoring of classified manufacturing areas, including viable and non-viable sampling.

• Conduct surface, air, personnel, and utility monitoring in accordance with SOPs and GMP requirements.
• Collect and document samples from cleanrooms, water systems, compressed gases, and manufacturing environments.
• Trend and analyze environmental monitoring data and identify adverse trends or excursions.
• Support investigations related to environmental monitoring deviations, out-of-specification (OOS), and contamination events.
• Review and maintain accurate laboratory documentation, logbooks, and electronic records.
• Ensure compliance with FDA, EMA, USP, and internal quality standards.
• Participate in cleanroom qualification, validation, and requalification activities.
• Assist with CAPA implementation and effectiveness checks.
• Maintain laboratory equipment and coordinate calibration and preventive maintenance activities.
• Support internal and external audits and regulatory inspections.
• Train junior analysts and support continuous improvement initiatives within the QC microbiology group.

Qualifications:

• Bachelor’s degree in Microbiology, Biology, Chemistry, or related scientific discipline.
• Minimum of 5 years of Environmental Monitoring experience in a pharmaceutical, biotechnology, or sterile manufacturing environment.
• Strong knowledge of GMP, aseptic processing, and cleanroom operations.
• Experience with viable/non-viable monitoring techniques and microbiological testing methods.
• Familiarity with FDA, EU GMP, USP <61>, <62>, <1116>, and related regulatory guidelines.
• Experience with deviation investigations, CAPA, and data trending.