Advanced Analytical Chemist

3 days ago

Waterford, Waterford, Ireland beBeeQuality Full time €60,000 - €80,000
Quality Assurance Specialist Role

We are seeking a skilled Quality Assurance Specialist to join our team in delivering world-class lifecycle services. The successful candidate will be responsible for ensuring the quality of sterile biologics and supporting investigations into particle origin.

The ideal candidate will have experience in analytical chemistry, particle analysis, and effective collaboration with cross-functional teams.

  • Main Responsibilities:
  • Provide high-quality 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 Standard Operating Procedures (SOPs) in line with regulatory and pharmacopoeial requirements.
  • Train analysts in relevant methods, SOPs, and technical updates.
  • Monitor and trend analytical results, complete Certificates of Analysis (COAs), and support Out-of-Specification (OOS) investigations.
  • Ensure all laboratory records and documentation are accurate, current, and compliant.
  • Ensure Quality Control laboratories operate in compliance with Current Good Laboratory Practice (cGLP).
  • Verify that chemical testing and related equipment meet validation requirements (IQ, OQ, PQ).
  • Review and audit laboratory notebooks, analytical reports, and chemistry test results to ensure compliance with cGLP and cGMP.
  • Identify potential issues and highlight improvements to the QC Team Lead.

Key Skills and Qualifications:

  • Experience in analytical chemistry and particle analysis.
  • Effective communication and collaboration skills.
  • Ability to work in a fast-paced environment and prioritize tasks.
  • Strong attention to detail and organizational skills.

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