Quality Control Analyst

2 weeks ago

Bray, Wicklow, Ireland HRM Full time

Our client is a leading global Biopharmaceutical company dedicated to supporting customers and their businesses in ever better ways. This organisation delivers quality medicines and vaccines, complemented by diagnostic products, genetic tests, biodevices, and a range of services. Selling in over 100+ countries with over 10,000 employees, this organisation is one of the largest healthcare organisations in its defined sector.

They are currently looking for a Quality Control Analyst to join their operation and are located less than 1 hour from Dublin.

This is a shift role with 33% shift allowance and the shift is a 4-shift cycle. 7-7 2 days on, 2 nights on, 4 days off.

Responsibilities

  • The QC Analyst reports to the Site Quality Control Lead and will be responsible for all QC test activities including, but not limited to, testing of incoming materials, in process materials, intermediate, API and stability samples, method transfer and validation, and data review.
  • Development, validation and transfer of analytical methods, including cleaning method validation and associated troubleshooting, as required.
  • Carrying out method reviews and peer reviews.
  • Analytical support to include monitoring of production and analytical results throughout the technology transfer and process validation phases.
  • Preparation & review of laboratory documentation (e.g. method transfer and validation protocols and reports, SOP's, calibration procedures, analytical test records and miscellaneous protocols).
  • Testing of raw material, intermediates, API's, and materials associated with the reaction process and cleaning process in accordance with approved procedures including the stability testing program.
  • Testing of swab and rinse samples and visual inspection of equipment after cleaning.
  • Sampling and testing of support utilities (water, nitrogen, steam, environmental monitoring).
  • Review and accuracy check of analytical data.
  • Active participation in laboratory tier meetings.

Experience

  • Bachelor of Science in Chemistry with 3+ years of quality control and analytical laboratory experience.
  • Advantageous to have Analytical Method Validation Experience.
  • Recognised LSS Qualification (Yellow Belt, Green Belt, Black Belt) desirable.

To learn more about this role apply online or contact Treasa Prior on +353 87 398 3226 for a confidential discussion.

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