Quality Operations QC Analyst – Biologics & Vaccines

Next Generation; Carlow; On-site; EUR 60,000 - 80,000; Full time

Job summary

Next Generation is seeking a QC Analyst for its Quality Operations Laboratory in Ireland. You will perform analytical testing to support release of biologics and vaccines in a GMP-regulated setting, transfer methods, validate analyses, and contribute to data integrity and inspection readiness.

The role involves advanced techniques (HPLC, ELISA, cell-based assays, cell culture) and supporting OOS investigations, CAPA actions, and cross-functional collaboration. Rotating shifts apply.

Qualifications

• Bachelor’s degree in Analytical Chemistry, Biochemistry, or Life Science.
• Approximately 2–3 years of experience in a pharmaceutical Quality Control lab.
• Hands-on experience with HPLC and associated software.
• Experience performing ELISA, Cell-Based Assays, and Cell Culture techniques.
• Solid understanding of cGMP, GLP, and Quality Management Systems.
• Strong attention to detail and data integrity practices.

Responsibilities

• Perform analytical testing to support release of biologics, vaccines, and products in a GMP-regulated environment.
• Carry out analytical method transfers, method validation, and commercial product testing.
• Perform advanced lab techniques including HPLC (HIC, IEX, HP-SEC), ELISA, Cell-Based Assays, Cell Culture, Capillary Electrophoresis, and other compendial methods.
• Review laboratory documentation to ensure data integrity and Right First Time (RFT) results.
• Support Out of Specification (OOS) investigations and CAPA actions.
• Participate in daily lab operations ensuring timely, safe and accurate testing.
• Prepare, review, and update SOPs and training documentation for compliance.
• Support internal and external audits and inspections, maintaining readiness.
• Contribute to continuous improvement using Root Cause Analysis, FMEA, Fishbone, and 5 Whys.
• Collaborate with cross-functional teams to foster a safe, compliant lab culture.

Skills

Analytical mindset

Attention to detail

Troubleshooting

Communication skills

Education

Bachelor's degree in Analytical Chemistry, Biochemistry, or Life Science

Tools

HPLC software

Job description

Next Generation is seeking a QC Analyst for its Quality Operations Laboratory in Ireland. You will perform analytical testing to support release of biologics and vaccines in a GMP-regulated setting, transfer methods, validate analyses, and contribute to data integrity and inspection readiness.

The role involves advanced techniques (HPLC, ELISA, cell-based assays, cell culture) and supporting OOS investigations, CAPA actions, and cross-functional collaboration. Rotating shifts apply.