Quality Assurance Specialist

Posted 14 Days Ago
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Portsmouth, Hampshire, England, GBR
In-Office
Mid level
Healthtech • Other • Software • Biotech
The Role
Provide QMS support for laboratory and site operations within ISO 9001/GMP environments. Maintain QMS processes (deviations, CAPA, document/change control), support audits, embed quality and data integrity, and maintain QA records and metrics.
Summary Generated by Built In

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 Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. 

You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s 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 non‑manufacturing 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 day‑to‑day 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 follow‑up 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 decision‑making and QMS effectiveness.

Education

  • Bachelor’s degree (or equivalent) in an applicable scientific discipline.

Experience

  • Typically 2–4 years’ experience in a Quality Assurance or Quality Systems role, within a regulated or ISO‑certified 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 problem‑solving 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, we’ll accelerate the real-life impact of tomorrow’s 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.

For more information, visit www.danaher.com.

Skills Required

  • Bachelor's degree (or equivalent) in a scientific discipline
  • 2-4 years' experience in Quality Assurance or Quality Systems in a regulated or ISO-certified environment
  • Working knowledge of ISO 9001 and core QMS principles
  • Familiarity with GMP expectations applicable to laboratory services
  • Experience with deviations, CAPAs, document control, change control, risk management, training compliance, complaints handling and audits
  • Strong analytical and problem-solving skills to investigate issues and support corrective actions
  • Clear written and verbal communication skills and ability to work cross-functionally

Beckman Coulter Diagnostics Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Beckman Coulter Diagnostics and has not been reviewed or approved by Beckman Coulter Diagnostics.

  • Healthcare Strength Healthcare coverage is described as comprehensive, including medical, dental, vision, life and disability insurance, flexible spending accounts, and mental health support. Feedback suggests these offerings are a notable strength of the overall package.
  • Leave & Time Off Breadth Paid time off, paid holidays, sick days, and volunteer time are highlighted, with flexibility or remote arrangements available for some roles. Feedback suggests this breadth of time-off options contributes meaningfully to total rewards.
  • Parental & Family Support Paid parental leave is provided for birth, adoption, or foster placement with the ability to use time in flexible increments within the first year. Feedback suggests family-focused perks like adoption support add tangible value for caregivers.

Beckman Coulter Diagnostics Insights

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The Company
HQ: Brea, CA
10,526 Employees
Year Founded: 1935

What We Do

Beckman Coulter is committed to advancing healthcare for every person by applying the power of science, technology, and the passion and creativity of our teams to enhance the diagnostic laboratory’s role in improving healthcare outcomes. Our diagnostic systems are used in complex biomedical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. Beckman Coulter offers a unique combination of people, processes and solutions designed to elevate the performance of clinical laboratories and healthcare networks. We do this by accelerating care with a menu that matters, bringing the benefit of automation to all, delivering greater insights through clinical informatics and unlocking hidden value through performance partnership. An operating company of Danaher Corporation since 2011, Beckman Coulter is headquartered in Brea, Calif., and has more than 11,000 global associates working diligently to make the world a healthier place.

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