Senior QA Specialist - Quality Management System

Publiceringsdatum: 2024-12-18

Letar du efter anställning inom yrken med teknisk inriktning? Här är din möjlighet att bli en del av teamet hos Cytiva Sweden AB genom att arbeta som kvalitetsingenjör, kemiteknik/kvalitetstekniker, kemiteknik. Cytiva Sweden AB söker någon som vill arbeta heltid under tills vidare. Kanske är det du?

För detta jobb är Uppsala den angivna tjänsteorten. Cytiva Sweden AB har just nu ett ledigt jobb som kvalitetsingenjör, kemiteknik/kvalitetstekniker, kemiteknik. Sök jobbet som kvalitetsingenjör, kemiteknik/kvalitetstekniker, kemiteknik hos Cytiva Sweden AB och ta chansen att ta din karriär till nästa nivå. Ansök senast fredag den sjuttonde januari 2025.

Jobbannons

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.

We’re looking for a Senior QA Specialist – Quality Management System to join Cytiva’s Quality Assurance Department located at our manufacturing site in Uppsala. In this role, you will be responsible for independently managing documentation within the eDMS as required to support the Uppsala QMS. As Senior QA Specialist, you will coordinate the management of documents and take on the role as Site Subject Matter Expert for our eDMS, coaching individuals on how to write instructions and chair the site Document Review Board. In addition, you will support the assignment of QMS Training and the overall performance of and compliance to the Uppsala QMS together with QA Leaders. This is a highly dynamic role where you will have many cross functional interactions, both local and global. This position is an onsite role.

What you will do

• Lead and develop the Quality Management System (QMS) ensuring the effectiveness of QMS and its documentation.
• Lead the QMS Documentation Review Board including multi-site documentation ensuring the QMS documentation process is effective and continuously improved by monitoring performance.
• Act as Site subject matter expert (SME) for our document management system (eDMS) and in global forums.
• Monitor changes in global and external documents and assure that relevant changes are initiated and managed in the site QMS document process.
• Work closely with the Site QA Leader and the respective SME to understand, develop and harmonize the QMS and related documentation and training.
• Support the QMS Training Lead and the Line and Quality Managers with the planning and organizing of QMS Training, ensure the training matrix is updated, track QMS Training metrics and create training material as relevant
• Administrate the QA webpage on Cytiva's intranet.

The essential requirements of the job include

• Bachelor’s degree or high school diploma in a relevant field.
• A few years experience of working in an documentation-focused role within a ISO9001, 13485 or cGMP regulated environment.
• Ability to communicate effectively in Swedish and English, both written and oral.
• Experience working with computerized systems.
• Proficient user of Microsoft Office software. Advanced skills in Excel is a plus.

To be successful in this role, we believe that you are a highly engaged and self-motived individual with excellent networking, interpersonal and communication skills. In addition, we're looking for someone who is very structured, enjoys problem-solving and troubleshooting, with the ability to work effectively both independently and with others. The ideal candidate should possess a service-oriented mindset, demonstrate unwavering integrity, prioritize quality, and consistently meet deadlines.

Interview and selection will happen continuously and the opening can be filled before last day of application. For questions regarding the role please contact hiring manager Camilla Lindgren, QA Section Manager, camilla.lindgren@cytiva.com.

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.