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.