Quality Control Analyst

CareerWise Recruitment; Waterford; On-site; EUR 40,000 - 60,000; Full time

Job summary

CareerWise Recruitment is seeking a QC Analyst for a leading pharmaceutical company in Waterford on a 23-month contract. You will perform analytical chemistry testing and ensure compliance with cGMP/cGLP standards to support the release of raw materials, intermediates, and finished products.

You will lead investigations of OOS results, maintain methods and SOPs, support IQ/OQ/PQ for laboratory instrumentation, and train analysts while collaborating with QA, Production, Engineering, Planning, and

Qualifications

• Bachelor’s degree in Chemistry or related scientific discipline.
• Proven GMP-regulated environment experience.
• In-depth understanding of cGMP/cGLP guidelines and data integrity principles.
• Strong data review, investigation documentation, and technical record-keeping.

Responsibilities

• Perform analytical chemistry testing in compliance with cGMP/cGLP and data integrity standards.
• Lead investigations into OOS results and generate CoAs.
• Maintain, update, and review analytical methods, specs, notebooks, and SOPs.
• Support IQ/OQ/PQ for laboratory instrumentation.
• Train analysts on methods, SOPs, and testing procedures.
• Partner with QA, Production, Engineering, Planning, and QC teams to drive success.

Skills

Analytical chemistry

GMP compliance

Data integrity

Cross-functional collab

Education

Bachelor’s degree in Chemistry

Tools

SoftMax® software

Job description

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, and HIAC particulate testing.
• SoftMax® software proficiency, precision micropipetting techniques, and strong time management skills.