Senior QA Specialist

Cytivalifesciences; Portsmouth; On-site; GBP 40,000 - 60,000; Full time

Job summary

Cytivalifesciences is seeking a Senior QA Specialist at its Stevenage site in England. This crucial role involves overseeing the Quality Management System, supporting change control and CAPA processes, and ensuring compliance with industry standards. Candidates should possess a relevant degree and experience in QA within life sciences, particularly with ISO and GMP regulations. Join a team dedicated to making impactful changes in life sciences.

Qualifications

• Experience in a similar QA role in life sciences.
• Familiarity with ISO standards and GMP regulations.
• Participated in QA projects and risk assessments.

Responsibilities

• Represent QA in cross-functional projects and ensure compliance with QMS.
• Review and approve Change Control, CAPA, and batch release.
• Drive improvement activities within the QMS.

Skills

Quality Management System (QMS)

Risk Assessment

ISO 9001

ISO 13485

GMP

Education

Relevant Bachelor's degree in Chemistry or Pharmacy

Job description

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.

Are you our new Senior QA Specialist at Stevenage Site UK, reporting to the Quality Assurance department at Cytiva Uppsala, Sweden. 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 Batchelor degree within chemistry/ Pharmacy or equivalent
• Experience of similar QA-role within Life Science companies (t.ex 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.

For more information, visit www.danaher.com.

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.