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QC Laboratory Lead

  • Sector: Science & Pharma
  • Contact: Aisling Lane
  • Contact Email:
  • Job Ref: 17903

A unique opportunity has presented itself for an experienced QC Laboratory Lead to join a leading US organisation in their new start-up Manufacturing and Operations Centre in the Limerick region. This organisation is a leading supplier of contract formulation and manufacturing services to the life science industry.

The QC Lead position works with the site manager and site management team and serves as a subject matter expert in the QC Laboratory. The QC Lead is responsible for ensuring that daily laboratory testing of raw materials, in-process and finished products are completed as required.

Overview of Main Responsibilities (full job description available on request):       

  • Manage day-to-day shift prioritization of routine, in-process, stability, and finished product work.

  • Work with management to maintain working schedule of all work flowing through the QC Analytical Lab.

  • Lead training of all new employees and maintain all training documentation via the current system.

  • Directs implementation of the OOS system Laboratory Investigations, and assist in any related CAPAs, deviations, etc.

  • Perform advanced chemical testing using analytical instrumentation including HPLC, GC, FTIR, UV-VIS, etc.

  • Provide help with troubleshooting of analytical instrumentation and basic maintenance.

  • Facilitate QC audit readiness with an understanding of FDA and ISO regulations and requirements.

  • Support on-time performance in the QC lab against the Production and laboratory schedules.

  • Review batch records to ensure they are compliant with SOPs, WIs, and cGMPs.

  • Assist in writing and revising SOPs and WIs to ensure cGMP compliance.

  • Follow all SOPs and Safety Guidelines to ensure compliance with a cGMP environment and Safety Practices

What the ideal candidate looks like:

  • B.S. in Chemistry or related scientific field 4+ years related experience or M.S. in Chemistry or related scientific field 2+ years related experience.

  • Experience working in a GMP regulated environment.

  • Expertise with Empower.

  • Ability to manage and lead teams.

  • Understanding of LIMS.

For a confidential discussion and more information on the role, please contact Aisling Lane.

(021) 4320675