QC Scientist and Associate Director

2 weeks ago


Dundalk, Louth, Ireland Wuxi Biologics Ireland Limited Full time

The ideal candidate for this position will have a strong background in Quality Control, with experience working in a greenfield context of similar size and scale. Responsibilities include:

  • Serving as a technical expert supporting non-conformances, investigations, change controls, deviations, and CAPAs
  • Developing and maintaining high-level scientific achievements for the company
  • Leading a team of QC In Process Scientists and Associate Scientists, providing guidance and direction, performance management, training plans, and direct 1-2-1 communication

Requirements:

  • 8+ years of experience working within a Quality Control environment, with a well-rounded exposure to all areas in this field
  • Previous experience handling regulatory inspections from FDA, EMA, etc., and GMP audits from clients, as well as internal Quality Assurance is advantageous
  • Technical expertise in tech transfer, validation, and troubleshooting Biologics in-process forward processing test methods, including HPLC Titer Determination and UV Protein Concentration to support in a GMP-environment according to USP, EP, and ChP requirements


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