Senior QA Specialist

Danaher - Global; Stevenage; On-site; GBP 35,000 - 65,000; Full time

Job summary

An established industry player is seeking a Senior QA Specialist to join their team at the Stevenage site. This pivotal role involves overseeing quality management systems and batch release, ensuring compliance with industry standards. As part of a collaborative environment, you will engage in cross-functional projects, driving improvements and supporting the organization in maintaining high-quality standards. If you're passionate about making a tangible impact in life sciences and thrive in a culture of belonging, this is your opportunity to contribute to life-saving innovations.

Qualifications

• Experience in a similar QA role within Life Science companies.
• Knowledge of QMS processes and compliance requirements.

Responsibilities

• Represent QA in cross-functional projects and support QMS processes.
• Review and approve Change Control, CAPA, and risk assessments.

Skills

Quality Assurance

Change Control

CAPA

Deviation Handling

Risk Assessment

Batch Release

Education

Bachelor's degree in Chemistry

Bachelor's degree in Pharmacy

Tools

ISO 9001

ISO 13485

GMP

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 a 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 a 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.
• 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 counterpart to approve qualification activities to meet set timelines and project plans, in close collaboration with 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's degree in Chemistry, Pharmacy, or equivalent.
• Experience in a similar QA role within Life Science companies (e.g., ISO 9001, ISO 13485, and/or GMP).
• Experience as QA in projects.
• Experience of Qualification activities within automation, equipment, and analytical methods.
• Previous 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.