QC Analyst

Join our client and play a key role in maintaining top-tier quality standards! If you have a keen eye for detail and a passion for analysis, this could be your perfect hybrid-working opportunity.

Proclinical is seeking a QC Analyst to join the Foreign Matter Team within the MSAT Laboratory. In this role, you will focus on isolating particles from sterile biologics and supporting investigations to determine their origin using advanced analytical techniques. This is a hybrid position requiring three days on-site, with flexibility for remote work based on team needs and training requirements.

Responsibilities:

• Isolate particles from sterile biologics and contribute to investigations into their origin.
• 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.

Key Skills and Requirements:

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

If you are having difficulty in applying or if you have any questions, please contact Numhom Sudsok at n.sudsok@proclinical.com.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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