Environmental Monitoring Analyst

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!