Role OverviewWe are seeking an Environmental Monitoring Analyst to support a growing pharmaceutical/life sciences organization in Durham, NC. This is an excellent opportunity for a GMP professional with Environmental Monitoring experience to support EU GMP Annex 1 readiness, contamination control, and continuous improvement initiatives.
What You Will Do
Support EU GMP Annex 1 gap assessments and remediation activities, review viable/non-viable EM data, and prepare and update GMP documentation.
Why It Might Be a Fit
Join a team making an impact in GMP compliance, Environmental Monitoring, and contamination control.
Requirements
- Bachelor's degree in Microbiology, Life Sciences, Biotechnology, Pharmaceutical Sciences, Engineering, or related field
- Knowledge of Environmental Monitoring, GMP, cleanroom practices, aseptic processing, and contamination control
- Understanding of EU GMP Annex 1 and EM programs
- Experience with EM data review, trending, alert/action levels, and sampling strategies
- Familiarity with FMEA, HACCP, CCS, CAPA, ISO 14644, or regulatory inspections is a plus
- Strong written, verbal, and technical documentation skills
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