QC Analyst

A QC Analyst is required for a leading pharmaceutical Company based in Waterford This is a 23 month contract. In this role, you will provide critical analytical chemistry testing and operational support to ensure full compliance with cGMP/cGLP standards and support the timely release of raw materials, intermediates, and finished products.

THE ROLE

• Perform and review analytical chemistry testing and laboratory data in compliance with cGMP, cGLP, and data integrity standards.
• Lead investigations into Out-of-Specification (OOS) results, generate Certificates of Analysis (CoAs), and support ongoing data trending.
• Maintain, update, and review analytical methods, specifications, laboratory notebooks, and SOPs in line with evolving regulatory standards.
• Support installation, operational, and performance qualifications (IQ/OQ/PQ) for laboratory instrumentation.
• Train analysts on laboratory methods, updated SOPs, and testing procedures.
• Partner effectively with QA, Production, Engineering, Planning, and QC teams to drive operational success.

REQUIREMENTS

• Bachelor's degree in Chemistry, Biochemistry, or a related scientific discipline (or equivalent experience).
• Proven analytical chemistry experience within a GMP-regulated environment.
• In-depth understanding of cGMP/cGLP guidelines and data integrity principles.
• Strong track record in data review, investigation documentation, and technical record-keeping.
• Excellent cross-functional communication and collaborative problem-solving skills.

Preferred Technical Experience

• ELISA
• SDS-PAGE
• Biacore receptor-binding assays
• UV analysis
• Osmolality
• Karl Fischer moisture testing
• Oxygen headspace analysis
• HIAC particulate testing
• SoftMax software proficiency, precision micropipetting techniques, and strong time management skills.