Environmental Monitoring Analyst(GMP)

• Position Title: EM Analyst
• Location: Durham, NC
• Duration: 6 Months

Job Description:

We are looking for an Environmental Monitoring (EM) Analyst with 1–2 years of experience in a GMP-regulated pharmaceutical/biopharmaceutical environment and basic knowledge of EU GMP Annex 1.

• Key Responsibilities
• Perform routine Environmental Monitoring activities in classified cleanrooms.
• Conduct viable/non-viable monitoring, including air, surface, settle plate, and personnel monitoring.
• Maintain EM records and support data review and trending.
• Support investigation of EM excursions, deviations, and OOS/OOT results.
• Follow GMP, EU GMP Annex 1, SOPs, and data integrity requirements.
• Support contamination control and cleanroom monitoring activities.

• Required Skills
• 1–2 years of Environmental Monitoring experience in Pharma/Life Sciences.
• Basic understanding of EU GMP Annex 1.
• Knowledge of GMP, cleanroom practices, and aseptic environments.
• Familiarity with EM sampling and documentation.
• Good analytical, documentation, and communication skills.
• Microbiology/Life Sciences background preferred.