Environmental Monitoring Analyst

$35 per hour

Spark Recruiting

Durham, NC

Job Description

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!

Apply

Vacancy posted 4 days ago

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