Senior Analytical Quality Control Specialist

24 hours ago

Waterford, Waterford, Ireland beBeeAnalytical Full time €60,000 - €90,000
Job Overview

A Quality Assurance Specialist plays a pivotal role in upholding the highest standards of quality. If you possess an analytical mind and a keen eye for detail, this could be your ideal opportunity.

The position requires a flexible working setup with three days on-site and adaptability for remote work based on team needs and training requirements.

Key Responsibilities:

  • Conduct thorough investigations into particle origins and contribute to their isolation from sterile biologics.
  • Perform 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.

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