QC Analyst

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

QC Analyst - Quality Operations Laboratory

Imagine being part of a laboratory team responsible for ensuring the quality, safety, and integrity of biologics and vaccines that reach patients around the world. Every sample you analyze, every method you validate, and every quality investigation you support helps ensure life-changing medicines are released safely and in full compliance with the highest regulatory standards.

This opportunity is based within a growing, state-of-the-art Quality Operations laboratory where collaboration, scientific excellence, and continuous improvement are at the heart of everything. You'll work alongside experienced scientists in a GMP-regulated pharmaceutical manufacturing environment, gaining exposure to advanced analytical technologies while developing your career in pharmaceutical quality.

What you’ll achieve (and why it matters):

Bring your analytical expertise into a modern pharmaceutical laboratory where quality drives every decision:

• 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 structured problem-solving tools such as Root Cause Analysis, FMEA, Fishbone Diagrams, and 5 Whys.
• Collaborate with cross-functional teams to promote a safe, compliant, and quality-focused laboratory culture.

Your edge (desired, not required):

• Bachelor's degree in Analytical Chemistry, Biochemistry, or another relevant Life Science discipline.
• Approximately 2-3 years' experience within 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.
• Strong attention to detail with excellent documentation and data integrity practices.
• Analytical mindset with strong troubleshooting and problem-solving abilities.
• Excellent communication skills and the ability to work effectively within a collaborative laboratory team.
• Comfortable working a rotating two-cycle shift pattern.

Why this role matters:

This is more than a laboratory position; it's an opportunity to contribute to the manufacture of medicines that improve and save lives. You'll join a technically driven Quality Operations team, work with cutting-edge analytical technologies, and play a vital role in ensuring every product released meets the highest standards of quality, safety, and regulatory compliance.