Quality Control Analyst – Pharmaceutical / Biopharmaceutical
We are currently looking for a QC Analyst to join a state‑of‑the‑art Quality Operations laboratory in Carlow, supporting the testing and release of pharmaceutical and biopharmaceutical products.
We are particularly interested in candidates with hands‑on experience in HPLC and associated software, ELISA, Cell Based Assays and Cell Culture.
Key Responsibilities
- Perform QC laboratory testing in line with company safety policies, cGMP, cGLP, procedures and regulatory requirements.
- Perform analytical testing including HPLC (HIC, IEX, HP-SEC), ELISA, Cell Based Assays, Cell Culture, Capillary Electrophoresis (CE) and other compendial test methods.
- Support analytical method transfers, validation and commercial testing activities.
- Participate in QC Tier 1 daily meetings, communicating testing progress, deviations and other relevant updates.
- Prepare and update operational procedures, training materials and maintenance procedures, ensuring work is completed in line with approved requirements.
- Complete data processing and reviews, peer review testing documentation, and ensure data integrity and Right First Time (RFT) KPIs are achieved.
- Participate in OOS investigations, continuous improvement and root cause analysis, using tools such as FMEA, Fishbone diagrams and 5 Whys to resolve system and equipment issues.
- Support audit and inspection readiness, participate in internal and external audits as an auditee, and work collaboratively to maintain a safe and compliant culture on site.
Skills & Experience
- Bachelor’s Degree or higher preferred, ideally in Analytical Chemistry, Biochemistry or a closely related discipline.
- Ideally 2–3 years’ experience in a pharmaceutical laboratory, with experience in HPLC, Cell-Based Assays and relevant systems and software.
- Good working knowledge of Immunoassay, Cell Culture, HPLC systems and software is desirable.
- Good knowledge of cGMP, GLP and Quality Management Systems.
The position is 100% onsite in Carlow, and candidates must be available to work both shifts.
- 11-month contract role
- Location: Carlow – 100% Onsite
- €20.00 per hour + 20% Shift Premium
- 2-Cycle Shift Pattern
- Week 1: 7:00am – 3:00pm
- Week 2: 3:00pm – 11:00pm