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- Tasks: Join our QA team to ensure compliance and support life-saving projects.
- Company: Cytiva, part of Danaher, innovates in life sciences and biotechnology.
- Benefits: Enjoy a culture of belonging, continuous improvement, and impactful work.
- Why this job: Make a real difference in health while collaborating with passionate teams.
- Qualifications: Bachelor's degree in chemistry/pharmacy and experience in QA roles required.
- Other info: This is an on-site role at our Stevenage site in the UK.
The predicted salary is between 36000 - 60000 £ per year.
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.
As Senior QA Specialist you will be part of the QA team at site that has the oversight of QMS-management and batch release. You will have supporting function to the organization within Change Control, CAPA, NC (deviation) and complaints handling. You will represent QA in projects and ensure compliance to the design control procedure and QMS. In this role you will work in cross-functional team with the rest of the site as manufacturing and R&D and also teams from Uppsala. This is an on-site role at Stevenage site UK.
In this role you will:
- Represent QA in cross-functional projects as new product- and equipment projects.
- Represent QA on site to support the organization within the QMS processes; Change Control, CAPA, NC and batch release.
- Review and approve Change Control, CAPA, NC.
- Perform batch release.
- Be the QA counter part to approve qualification activities to meet set timelines and project planes, in close collaboration to the rest of the organization.
- Represent QA in cross functional risk assessments.
- Review and approve risk assessments and qualification documentation.
- Participate and actively drive improvement activities within the QMS, in projects and processes.
- Ensure compliance with the Quality Management System (QMS) in close collaboration with the rest of the organization and the Uppsala QA organization.
Who you are:
- Relevant Bachelor degree within chemistry/ Pharmacy or equivalent.
- Experience of similar QA-role within Life Science companies (e.g. ISO 9001, ISO 13485 and/or GMP).
- Experience of being QA in projects.
- Experience of Qualification activities within automation, equipment and analytical methods.
- Earlier experience as QA in risk assessments/FMEA, batch release and deviations/NC.
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. At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
Senior QA Specialist employer: Cytiva
Contact Detail:
Cytiva Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior QA Specialist
✨Tip Number 1
Familiarise yourself with the Danaher Business System. Understanding how this system drives continuous improvement and innovation will not only help you in interviews but also demonstrate your commitment to the company's values.
✨Tip Number 2
Network with current employees at Cytiva or within the life sciences sector. Engaging with professionals in the field can provide insights into the company culture and expectations, which can be invaluable during your application process.
✨Tip Number 3
Prepare to discuss specific examples of your experience with QMS processes, particularly in Change Control and CAPA. Being able to articulate your hands-on experience will set you apart from other candidates.
✨Tip Number 4
Stay updated on the latest trends and regulations in the life sciences industry, especially those related to quality assurance. This knowledge will not only enhance your confidence but also show your dedication to staying relevant in the field.
We think you need these skills to ace Senior QA Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in Quality Assurance, particularly within life sciences. Emphasise your familiarity with ISO standards and any specific QA roles you've held that align with the job description.
Craft a Compelling Cover Letter: Write a cover letter that not only outlines your qualifications but also demonstrates your passion for improving human health through quality assurance. Mention specific experiences that relate to the responsibilities listed in the job description.
Showcase Relevant Skills: In your application, clearly showcase skills such as Change Control, CAPA, and risk assessments. Use examples from your past work to illustrate how you have successfully applied these skills in similar roles.
Research Cytiva and Danaher: Familiarise yourself with Cytiva's mission and values, as well as the Danaher Business System. This knowledge will help you tailor your application and demonstrate your alignment with their commitment to innovation and impact.
How to prepare for a job interview at Cytiva
✨Understand the QMS
Make sure you have a solid grasp of Quality Management Systems (QMS) and relevant standards like ISO 9001 and ISO 13485. Be prepared to discuss how you've applied these in your previous roles, especially in relation to change control and CAPA.
✨Showcase Your Project Experience
Highlight your experience in cross-functional projects, particularly those involving QA. Be ready to share specific examples of how you contributed to project success and compliance with design control procedures.
✨Prepare for Technical Questions
Expect technical questions related to risk assessments, batch release processes, and qualification activities. Brush up on your knowledge of FMEA and be ready to explain how you've handled deviations and non-conformances in the past.
✨Demonstrate Continuous Improvement Mindset
Cytiva values innovation and continuous improvement. Prepare to discuss how you've driven improvement activities in your previous roles and how you can contribute to enhancing processes at Cytiva.
