GMP QC Analyst — Quality Operations Lab

Next Generation; Carlow; On-site; EUR 45,000 - 60,000; Full time

Job summary

Next Generation is seeking a QC Analyst to join its Quality Operations Laboratory, ensuring the quality, safety, and integrity of biologics and vaccines for patients worldwide. You will perform analytical testing under GMP, support method transfers and validation, and contribute to data integrity and continuous improvement within a regulated environment.

The role offers exposure to advanced analytics and a collaborative team, with a focus on Right First Time results and compliance across QA/QC

Qualifications

• Bachelor's degree in Analytical Chemistry or life sciences.
• 2–3 years' experience in pharmaceutical QC.
• Hands-on experience with HPLC and associated software.
• Experience with ELISA, cell-based assays, and cell culture.

Responsibilities

• Perform analytical testing to support release of biologics and vaccines within GMP.
• Carry out method transfers, validation activities, and product testing.
• Perform advanced techniques including HPLC (HIC, IEX, HP-SEC), ELISA, cell-based assays, and capillary electrophoresis.
• Review laboratory documentation and ensure data integrity while delivering Right First Time (RFT).
• Support Out of Specification (OOS) investigations and contribute to CAPA.
• Participate in daily laboratory operations, ensuring testing is completed safely, accurately, and within 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 RCA, FMEA, Fishbone Diagrams, and 5 Whys.
• Collaborate with cross-functional teams to promote a safe, compliant, and quality-focused laboratory culture.

Skills

HPLC

ELISA

Cell Culture

Data integrity

Education

Bachelor's degree in Analytical Chemistry

Job description

Next Generation is seeking a QC Analyst to join its Quality Operations Laboratory, ensuring the quality, safety, and integrity of biologics and vaccines for patients worldwide. You will perform analytical testing under GMP, support method transfers and validation, and contribute to data integrity and continuous improvement within a regulated environment.

The role offers exposure to advanced analytics and a collaborative team, with a focus on Right First Time results and compliance across QA/QC