Quality Specialist

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences diagnostics and biotechnology

At Cytiva one of Danahers 15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.

Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers system of continuous improvement you help turn ideas into impact innovating at the speed of life.

Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines new medicines and cell and gene therapies.

At Cytiva you will be able to continuously improve yourself and us working on challenges that truly matter with people that care for each other our customers and their patients. Take your next step to an altogether life-changing career.

Learn about the Danaher Business System which makes everything possible.

The Quality Specialist supports quality activities across the Cardiff Manufacturing Facility. The role focuses on non-conformance management complaint handling change control and maintenance of site quality systems.

This position reports to the Senior QA/QC Manager and is part of the Quality department located in Cardiff and will be an on-site role.

What you will do:

• 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.

Who you are:

• 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.

It would be a plus if you also possess previous experience in:

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

Cytiva a Danaher operating company offers a broad array of comprehensive competitive benefit programs that add value to our lives. Whether its a health care program or paid time off our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

This job is also eligible for bonus/incentive pay.

We offer comprehensive package of benefits including paid time off medical/dental/vision insurance and 401(k) to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole discretion unless and until paid and may be modified at the Companys sole discretion consistent with the law.

Join our winning team today. Together well accelerate the real-life impact of tomorrows science and technology. We partner with customers across the globe to help them solve their most complex challenges architecting solutions that bring the power of science to life.

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