Analytical Chemistry Specialist

4 days ago

Waterford, Waterford, Ireland beBeeQuality Full time €45,000 - €73,000

Highly skilled professionals are sought after by our esteemed organization to contribute to the excellence of quality standards in a dynamic hybrid-working environment.

We are looking for a talented QC Specialist to join the Foreign Matter Team within the MSAT Laboratory. In this role, you will be responsible for isolating particles from sterile biologics and supporting investigations into their origin using cutting-edge analytical techniques.

Main Responsibilities:

  • Isolate particles from sterile biologics and assist in investigations into their source.
  • Conduct advanced analytical techniques such as FTIR, Scanning Electron Microscopy, and RAMAN Spectroscopy.
  • Provide analytical chemistry services and support across the site.
  • Collaborate effectively with departments like Quality Assurance, Production, Engineering, and Planning.
  • Maintain and update chemical methods, specifications, and SOPs in compliance with regulatory standards.
  • Train analysts in new methods, SOPs, and areas of expertise.
  • Trend results, record data on Certificates of Analysis (COAs), and complete Out-of-Specification (OOS) investigations promptly.
  • Communicate potential issues and suggest improvements to the QC Team Leader.
  • Ensure all quality documentation and records are accurate and up-to-date.
  • Maintain compliance with current Good Laboratory Practice (cGLP) and Good Manufacturing Practice (cGMP).
  • Validate critical testing equipment and ensure it meets IQ, OQ, and PQ requirements.
  • Audit and review test results, laboratory notebooks, and analytical reports for accuracy and compliance.

Key Skills and Requirements:

  • Proficiency in analytical techniques such as FTIR, Scanning Electron Microscopy, and RAMAN Spectroscopy.
  • A strong understanding of cGLP and cGMP requirements.
  • Experience in maintaining and updating SOPs and chemical methods.
  • The ability to collaborate across departments and communicate effectively.
  • Skill in conducting investigations and trend analysis.
  • Attention to detail in auditing and reviewing laboratory documentation.
  • Familiarity with validation processes for testing equipment.

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