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.
Role Summary
The Quality Assurance Specialist works with a small team to provide Quality Management System (QMS) support to global laboratory services teams (Validation Services and Process Development Services) and a local nonmanufacturing site (Harbourgate) both operating within ISO 9001 certified environments and supporting GMP bio-pharmaceutical customers.The role ensures QMS requirements are consistently applied maintained and evidenced across laboratory operations and site processes in line with customer certification and internal quality expectations
Key Responsibilities
- Support daytoday maintenance and effective use of the site Quality Management System in compliance with ISO 9001 and applicable GMP expectations.
- Contribute to quality processes such as deviations CAPAs document control change control risk management training compliance complaints management customer questionnaires and audits as applicable.
- Support preparation for participation in and followup of internal customer and certification audits.
- Partner with laboratory operations and support functions to ensure quality requirements are understood and embedded into routine activities.
- Promote a culture of compliance data integrity and continuous improvement using structured quality tools and standard procedures.
- Maintain accurate timely QA records and metrics to support decisionmaking and QMS effectiveness.
Education
- Bachelors degree (or equivalent) in an applicable scientific discipline.
Experience
- Typically 24 years experience in a Quality Assurance or Quality Systems role within a regulated or ISOcertified environment (e.g. life sciences laboratories pharma services).
Skills
- Working knowledge of ISO 9001 and core Quality Management System principles with the ability to apply procedures across laboratory operations and site processes.
- Strong analytical and problemsolving skills able to investigate issues assess risk and support effective corrective actions.
- Clear written and verbal communication skills with the ability to work collaboratively across functions and with external customers or auditors.
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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Required Experience:
IC
Employment Type : Full-Time
Experience: years
Vacancy: 1