Orion Group Life Sciences is recruiting a QC Analyst (Shift) on behalf of a Multinational Pharmaceutical client based in Carlow. This is an 11‑month contract with strong potential to extend. Occasional travel may be required for training. The laboratory operates 2‑cycle and 4‑cycle shifts.
Role Overview Join a growing Quality Control laboratory supporting the analysis of biologics and vaccines within a state‑of‑the‑art manufacturing site. This role supports analytical testing, method transfer, validation, and commercial product release, working within a GMP‑regulated environment.
Key Responsibilities Perform analytical testing of biologics and vaccine products using techniques such as HPLC (HIC, IEX, HP‑SEC), Capillary Electrophoresis, and compendial methods.
Support analytical method transfer, validation, and routine commercial testing activities.
Ensure all work is conducted in compliance with cGMP, cGLP, and regulatory requirements.
Participate in QC Tier meetings, communicating testing progress, issues, and deviations.
Author, review, and update SOPs, test methods, and training documentation.
Perform peer review of analytical data and documentation, ensuring data integrity and Right First Time (RFT) performance.
Support and participate in OOS and laboratory investigations, including root cause analysis.
Contribute to audit and inspection readiness, acting as SME/auditee when required.
Drive continuous improvement initiatives, applying tools such as FMEA, Fishbone, and 5 Whys.
Collaborate cross‑functionally to promote a safe, compliant, and high‑performing laboratory environment.
Skills & Experience Degree in Analytical Chemistry, Biochemistry, or related scientific discipline.
2–3 years’ experience in a GMP‑regulated laboratory environment.
Strong hands‑on experience with HPLC and analytical testing techniques.
Working knowledge of cGMP, GLP, and Quality Management Systems.
Experience with LIMS and laboratory documentation systems.
Exposure to method validation, method transfer, and investigation processes (OOS/OOT).
Strong attention to detail, problem‑solving ability, and data integrity focus.
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