Job Description

QC Analyst - Quality Operations Laboratory

Join a cutting-edge team advancing biologics and vaccines.

Step into a dynamic, expanding Quality Operations laboratory at a strategic manufacturing site producing the world's leading biologic and top vaccine. You'll contribute to analytical method transfers, validations, and commercial testing in state-of-the-art facilities. Reporting directly to the QC Manager, you'll help drive our lab's growth; bring your expertise and innovative approach to deliver real impact.

Key benefits of the role:

• Collaborative team: Focus on safety, compliance, and continuous improvement.
• Meaningful work: Support the release of blockbuster drug products through precise testing.

Core responsibilities:

• Perform advanced testing with techniques like HPLC (HIC, CE, IEX, HP-SEC), Capillary Electrophoresis, and compendial methods, fully compliant with cGMP and cGLP.
• Participate in daily QC Tier 1 meetings to report progress, deviations, and ensure smooth operations.
• Develop, revise, and implement procedures, training materials, and maintenance documentation for Quality systems.
• Conduct peer reviews for data integrity, achieve Right First Time KPIs, and lead laboratory aspects of OOS investigations.
• Prepare for and support audits/inspections, serve as auditee, and apply root cause analysis tools (FMEA, Fishbone, 5 Whys) to resolve issues.
• Promote a safe, compliant culture through effective teamwork.

Qualifications we value:

• Bachelor's degree or higher (ideally in Analytical Chemistry, Biochemistry, or related field).
• 2-3 years in a pharmaceutical lab, including HPLC experience and software proficiency; essential for product release.
• Strong knowledge of cGMP, GLP, and Quality Management Systems.
• Desired: Expertise in Analytical Method Transfer, LIMS, Sterility Testing, Laboratory Investigations, and related areas.

The Next Step for you:

Should this position be of interest to you please forward your CV to danielle.johnson@nextgeneration.ie from Next Generation Recruitment or apply on our website.

Next Generation are specialists in Supply Chain, Procurement, Engineering, Quality, Technical and Operation (permanent, contract and temporary) positions.

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