QC Analyst

Careerwise Recruitment; Waterford; On-site; EUR 50,000 - 60,000; Full time

Job summary

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

The role includes maintaining analytical methods, leading investigations into OOS results, and collaborating across QA, Production, Engineering, Planning and QC to maintain quality and compliance.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Analytical chemistry

GMP compliance

Data integrity

Cross-functional collaboration

Investigations

Education

Bachelor’s degree in Chemistry or related field

Tools

SoftMax software

SDS-PAGE

ELISA

UV analysis

Karl Fischer

Osmolality

HIAc particulate testing

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