GMP QC Compliance Associate — Investigations & CAPAs

Regeneron Ireland

Limerick

On-site

EUR 52,000 - 70,000

Full time

7 days ago
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Job summary

Regeneron Ireland is seeking a Temp Assoc QC Compliance Specialist to join the Quality Control team in Raheen, Limerick. The role focuses on leading investigations, deviations, and CAPAs to ensure cGMP compliance across chemistry, bioassay, microbiology, and virology laboratories.

Ideal candidates will have a BS/BA in a relevant field and 2+ years in QC or analytical sciences, with 5+ years for senior levels, demonstrating strong root cause analysis and documentation skills.

Qualifications

  • BS/BA in Chemistry, Biology or related field or equivalent experience.
  • 2+ years in Quality Control or Analytical Sciences in a cGMP environment.
  • 5+ years for Senior Specialist in Quality Control or Analytical Sciences in a cGMP environment.

Responsibilities

  • Lead and support laboratory investigations, deviations, and non-conformance activities.
  • Write and review investigation reports and quality documentation.
  • Perform root cause analysis and implement CAPAs.
  • Support timely implementation and monitoring of corrective and preventive actions.
  • Identify recurring trends and recommend process improvements to strengthen QC operations.

Skills

Laboratory investigations
Deviations handling
Root cause analysis
Quality documentation
GMP compliance
Cross-functional collaboration

Education

BS/BA in Chemistry or Biology

Job description

Regeneron Ireland is seeking a Temp Assoc QC Compliance Specialist to join the Quality Control team in Raheen, Limerick. The role focuses on leading investigations, deviations, and CAPAs to ensure cGMP compliance across chemistry, bioassay, microbiology, and virology laboratories.

Ideal candidates will have a BS/BA in a relevant field and 2+ years in QC or analytical sciences, with 5+ years for senior levels, demonstrating strong root cause analysis and documentation skills.

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