QC Analyst, Quality Operations Lab — GMP Biologics

Next Generation; Leinster; On-site; EUR 42,000 - 52,000; Full time

Job summary

Next Generation is seeking a QC Analyst for the Quality Operations Laboratory in Ireland. You will perform analytical testing on biologics, vaccines, and pharmaceuticals in a GMP-regulated environment, ensuring data integrity and timely release of products.

You will transfer methods, validate assays, and support OOS investigations while helping maintain inspection readiness and continuous improvement in collaboration with cross-functional teams.

Qualifications

• Bachelor's degree in Analytical Chemistry, Biochemistry or Life Science.
• Approximately 2-3 years' experience in a pharmaceutical Quality Control laboratory.
• Hands-on experience with HPLC and associated software.
• Experience performing ELISA, Cell-Based Assays and Cell Culture techniques.
• Good understanding of cGMP, GLP, and Quality Management Systems.

Responsibilities

• Perform analytical testing to support the release of biologics, vaccines and pharmaceutical products within a GMP-regulated environment.
• Carry out analytical method transfers, method validation activities, and commercial product testing to support manufacturing operations.
• Perform advanced laboratory techniques including HPLC (HIC, IEX, HP-SEC), ELISA, Cell-Based Assays, Cell Culture, Capillary Electrophoresis, and other compendial analytical methods.
• Review laboratory documentation and ensure data integrity while delivering Right First Time (RFT) performance.
• Support Out of Specification (OOS) investigations and contribute to identifying effective corrective and preventive actions.
• Participate in daily laboratory operations, ensuring testing is completed safely, accurately, and within required timelines.
• Prepare, review, and update SOPs, laboratory procedures, and training documentation to maintain compliance.
• Support internal and external audits and inspections while helping maintain inspection readiness.
• Contribute to continuous improvement initiatives using tools like Root Cause Analysis, FMEA, Fishbone Diagrams, and 5 Whys.
• Collaborate with cross-functional teams to promote a safe, compliant, and quality-focused laboratory culture.

Skills

Attention to detail

Documentation

Data integrity

Troubleshooting

Analytical mindset

Communication skills

Education

Bachelor's degree in Analytical Chemistry/ Biochemistry/ Life Science

Tools

HPLC

Job description

Next Generation is seeking a QC Analyst for the Quality Operations Laboratory in Ireland. You will perform analytical testing on biologics, vaccines, and pharmaceuticals in a GMP-regulated environment, ensuring data integrity and timely release of products.

You will transfer methods, validate assays, and support OOS investigations while helping maintain inspection readiness and continuous improvement in collaboration with cross-functional teams.