Environmental Monitoring Analyst Job at Spark Recruiting, Durham, NC

  • Spark Recruiting
  • Durham, NC

Job Description

Job Description

Job Description

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!

Job Tags

Contract work

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