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Open nowFirst seen 5 days ago

Environmental Monitoring Analyst

Spark154 open roles

Where
Durham, North Carolina, United States
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Your applicationOpen nowEnvironmental Monitoring AnalystSpark · Durham, North Carolina, United States

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Share of postings closed within
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  2. 4.5%3 days
  3. 12.3%7 days
  4. 19.3%14 days
  5. 35.6%30 days
  6. 58.1%60 days
This job: first seen 5 days ago

The posting

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!

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