Senior Quality Control Specialist

4 days ago


Limerick, Limerick, Ireland Regeneron Ireland DAC Full time
About This Role

We are seeking a highly skilled Senior Quality Control Specialist to join our team. In this role, you will be responsible for performing assay transfers, validation, and investigation activities for QC.

As a Senior Quality Control Specialist, your typical day might include:

  • Performing assay validation for QC
  • Reviewing new test procedures and assays
  • Evaluating and implementing new methodologies, techniques, and equipment as needed

You will also have the opportunity to generate and/or support compliance records, CAPAs, change controls, and deviation notifications as required.

In addition, you will evaluate assay performance through yearly method performance reports, facilitate assay transfers from R&D and to business partners, and perform additional studies supporting regulatory filing.

Key Responsibilities
  • Perform assay validation for QC
  • Develop and implement new methodologies, techniques, and equipment as needed
  • Generate and/or support compliance records, CAPAs, change controls, and deviation notifications as required
  • Evaluate assay performance through yearly method performance reports
  • Facilitate assay transfers from R&D and to business partners
  • Perform additional studies supporting regulatory filing
Requirements
  • PhD in Microbiology, Chemistry, Biology, or a related field with 2+ years of experience, preferably in the pharmaceutical or biotechnology industries
  • MSc with 7+ years of proven experience; or BSc with relevant technical background
  • Strong analytical and problem-solving skills
  • Excellent communication and interpersonal skills


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