QC External Lab Coordinator - Method Transfer Lead (GMP)

Regeneron Pharmaceuticals, Inc

Limerick

On-site

EUR 25,000 - 40,000

Full time

6 days ago

Be an early applicant

A complete application in a minute

Tailored resume and cover letter, ready to send.

Get past ATS filters

Job summary

Regeneron Pharmaceuticals, Inc in Ireland is seeking a QC External Laboratory Coordinator to join the Quality Control (QC) Support team. You will coordinate sample management and method transfer activities with external laboratories supporting manufacturing and quality control operations.

You will serve as SME for analytical and microbiological method transfers, partner with Quality Assurance, Manufacturing, and external laboratories to resolve quality issues, investigations, and technical

Qualifications

Bachelor's degree in Biology, Chemistry, Microbiology or related discipline.
Experience in quality control, analytical testing, microbiology or external laboratory management in a regulated industry.
Knowledge of GMP requirements and quality systems.
Experience with method transfers, investigations, change controls, or contract laboratory oversight is preferred.

Responsibilities

Coordinate sample management and method transfer activities with external laboratories supporting manufacturing and quality control operations.
Serve as SME for analytical and microbiological method transfers, ensuring successful execution and compliance.
Partner with QA, Manufacturing, and external laboratories to resolve quality issues, investigations, and technical challenges.
Review and approve method transfer documentation, quality records, and laboratory reports to support regulatory compliance.
Drive continuous improvement initiatives while maintaining quality systems, including change controls, CAPAs, and SOPs.