Sterile Biologics Specialist

5 days ago

Waterford, Waterford, Ireland beBeeChemist Full time €60,000 - €80,000
Job Summary:

Catalyx is seeking a Quality Control Analyst to work on our customer site in Waterford.

The successful candidate will be responsible for isolating particles from sterile biologics and supporting investigations into particle origin using advanced analytical techniques such as FTIR, scanning electron microscopy, and Raman spectroscopy.

  • Provide analytical chemistry services and support to site operations.
  • Perform particle analysis and support investigations into the source of foreign matter.
  • Collaborate effectively with Quality Assurance, Production, Engineering, and Planning departments.
  • Maintain, update, and issue chemical methods, specifications, and SOPs in line with regulatory and pharmacopoeial requirements.
  • Train analysts in relevant methods, SOPs, and technical updates.
  • Monitor and trend analytical results, complete COAs, and support OOS investigations.
Required Skills and Qualifications:

To be successful in this role, you will need:

  • A degree in Chemistry, Analytical Science, or a related discipline.
  • Experience in analytical testing within a GMP-regulated pharmaceutical or biopharmaceutical environment.
  • Hands-on expertise with particle characterisation techniques such as FTIR, Raman spectroscopy, and SEM.
  • Strong knowledge of cGMP and cGLP requirements.
Why Choose Us?

We value our people and offer a Total Rewards package, including great professional growth opportunities. We strive to create a diverse and inclusive workplace where all individuals are valued, respected, and supported.

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