Environmental Monitoring Analyst
Location:
Durham, NC
Job Type: 6-Month Contract
$35.00 an hour
We are seeking an Environmental Monitoring Analyst to support a growing pharmaceutical/life sciences organization. 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.
Key Responsibilities
- Support EU GMP Annex 1 gap assessments
and remediation activities.
- Review viable/non-viable EM data, sampling strategies, alert/action levels, and trends.
- Support risk assessments using FMEA, HACCP, or risk-ranking methodologies.
- Prepare and update GMP documentation, including gap assessments, CAPAs, SOPs, CCS documents, and trend reports.
- Support EM investigations, CAPA activities, audits, and regulatory readiness.
- Collaborate with Quality, Microbiology, Manufacturing, and cross-functional teams.
- 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.
Qualifications
Join a team making an impact in GMP compliance, Environmental Monitoring, and contamination control. Apply today!