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Senior Analytical Chemist

2 weeks ago


Waterford, Waterford, Ireland beBeeQuality Full time €56,000 - €84,000
QC Analyst Job Description

Key Role in Maintaining Top-Tier Quality Standards

Job Overview

The position of QC Analyst is a critical role within the Foreign Matter Team, focusing on isolating particles from sterile biologics and supporting investigations using advanced analytical techniques.

Responsibilities
  1. Isolate particles from sterile biologics and contribute to origin investigations.
  2. Perform FTIR, Scanning Electron Microscopy, and RAMAN Spectroscopy techniques.
  3. Provide analytical chemistry services and support across the site.
  4. Maintain and update chemical methods, specifications, and SOPs in compliance with regulatory standards.
  5. Train analysts in new methods, SOPs, and areas of expertise.
  6. Trend results, record data on COAs, and complete OOS investigations promptly.
  7. Communicate potential issues and suggest improvements to the QC Team Leader.
  8. Ensure accurate quality documentation and records.
  9. Maintain compliance with cGLP and cGMP requirements.
Requirements
  1. Proficiency in analytical techniques such as FTIR, Scanning Electron Microscopy, and RAMAN Spectroscopy.
  2. Strong understanding of cGLP and cGMP requirements.
  3. Experience in maintaining and updating SOPs and chemical methods.
  4. Ability to collaborate across departments and communicate effectively.
  5. Skilled in conducting investigations and trend analysis.
  6. Attention to detail in auditing and reviewing laboratory documentation.