QC Analyst

Role overview

This Quality Control Analyst position sits within the Quality Operations Laboratory and supports the testing, transfer, and validation work needed to keep products compliant with quality and regulatory standards. The role reports to the QC Manager and contributes to the laboratory’s growth through commercial testing and analytical method transfer/validation activities.

The team’s remit is to ensure materials used in products are manufactured, processed, tested, packaged, stored, and distributed to the highest quality standards while meeting all regulatory obligations. The work is part of a wider global manufacturing network focused on delivering a dependable, compliant supply to customers and patients worldwide.

This is an onsite contract role based in Carlow, County Carlow, Ireland. The position works on a two-cycle shift pattern and may involve occasional travel for training.

Key duties

• Follow the direction of the Quality Control Manager and carry out daily work in line with company safety rules, cGMP, cGLP, global policies, procedures, guidelines, and regulatory expectations.
• Take part in QC Tier 1 daily meetings and communicate progress, deviations, and any testing issues effectively.
• Help develop, update, and release accurate operating procedures, training documents, and maintenance procedures for quality systems, ensuring all activities align with the approved documentation.
• Work within the QC team to complete assigned laboratory testing and other analytical duties.
• Run analytical methods that may include HPLC, HIC, CE, IEX, HP-SEC, ELISA, cell-based assays, cell culture, capillary electrophoresis, and other compendial methods under GMP conditions.
• Review peer documentation, maintain data integrity, and support achievement of QC Right First Time KPIs.
• Complete assigned data processing and review work within required timelines.
• Support laboratory activities linked to OOS investigations.
• Assist with audit and inspection readiness to help ensure the department remains compliant.
• Participate in internal and external audits and inspections as the auditee for the areas assigned.
• Use structured problem-solving and continuous improvement tools such as FMEA, fishbone analysis, and the 5 Whys to identify root causes and resolve equipment or system issues.
• Contribute to a safe, compliant, and collaborative site culture.

Candidate profile

The preferred background is a bachelor’s degree or higher, ideally in Analytical Chemistry, Biochemistry, or a closely related area.

The role is best suited to someone with 2 to 3 years of experience in a pharmaceutical laboratory, preferably with hands-on exposure to HPLC, cell-based assays, relevant laboratory systems, and associated software. Practical experience supporting testing for release of drug products is important.

A solid understanding of immunoassay work, cell culture, HPLC systems, cGMP, GLP, and quality management systems is desirable.

Additional information

This role follows a two-cycle shift schedule. Occasional travel may be required for training purposes.

Contract position. No salary or stipend details were provided.

No vacancy count, start date, or application deadline was specified.

Openings are not listed in the source information.