Quality Specialist

Overview

The Quality Specialist supports quality activities across the Cardiff Manufacturing Facility, focusing on non‑conformance management, complaint handling, change control, and maintenance of site quality systems. This on‑site role reports to the Senior QA/QC Manager and is part of Cytiva’s Quality department.

• Drive compliance with QMS requirements and applicable regulatory standards across site quality activities.
• Monitor and report QMS performance and support site quality review forums, including daily management, CAPA review board, and Management Review.
• Investigate product and process non‑conformances, perform root cause analysis, and implement and track CAPA effectiveness.
• Act as a subject matter expert within the Complaint Handling Program.
• Support change control, document management, training, audit readiness, external audits, and continuous improvement activities.

• Degree in Engineering, Science, Mathematics, or a similar analytical discipline preferred, or equivalent experience.
• Minimum 2 years’ experience in an ISO‑regulated, cGMP, ISO 13485, pharmaceutical, or FDA‑regulated manufacturing environment with strong quality exposure.
• Working knowledge of quality tools and techniques such as 5 Why, Ishikawa, SPC, Pareto, process capability studies, and risk management methods such as FMEA.
• Understanding of data integrity principles including ALCOA+ and familiarity with digital Quality Systems such as Veeva or equivalent.
• Proficiency in Microsoft Office applications, with strong Excel and PowerPoint skills desirable, and proficiency in English.

• Conducting internal audits, and supporting external customer and regulatory audits.

The position offers a comprehensive benefits package including paid time off, medical/dental/vision insurance, a 401(k) plan for eligible employees, and eligibility for bonus or incentive pay.