Quality Assurance Scientist - Plasma & Intermediates Release (60%)

Innovative and committed to patients worldwide.

CSL Behring is a leading global biotechnology company committed to its promise to save lives. At our site in Bern, we develop and produce life-saving therapies for people with serious and rare diseases worldwide.

For our Plasma & Intermediates Release Management team within the Quality Assurance Batch Release area, we are looking for a committed individual as

Quality Assurance Scientist - Plasma & Intermediates Release (60%) (m/w/d)

In this role, you are co-responsible for the technical assessment and release of our most important raw material, blood plasma, as well as intermediates, in accordance with applicable regulatory and internal quality requirements. In doing so, you check and evaluate quality-relevant information and data and ensure, through a careful and precise way of working, that our high quality standards are maintained.

The position combines independent, predominantly document- and system-based QA work with collaboration within our team and with other internal and international partners.

Competencies and responsibilities

• You undertake the technical assessment and release of blood plasma and intermediates according to current regulatory requirements and internal quality requirements.
• You independently process and evaluate re-donation information that may have an influence on the quality and safety of our products and ensure careful and traceable documentation.
• You create plasma certificates for intermediate and final products and ensure the complete and correct processing of the associated information and data.
• You create and update work instructions for internal procedures and processes and process change requests within your area of responsibility.
• You independently carry out smaller, cross-departmental projects and, depending on the topic, work together with various internal and international contact persons.
• You support the group leader during regulatory inspections and contribute to the continuous assurance of compliance through a reliable and GMP-compliant way of working.
• A significant part of your activity includes the careful checking, assessment, and documentation of information and data in various digital systems.

Qualifications and professional experience

• Completed Bachelor's or Master's degree in a scientific field, such as biology, chemistry, pharmacy, or a related field; a Master's degree is an advantage.
• Initial professional experience in quality assurance within a GMP-regulated pharmaceutical environment.
• Very careful, structured, and reliable way of working with a strong eye for detail and high quality awareness.
• Strong affinity for digital systems and data as well as the willingness to work with different IT applications; experience with SAP and/or statistical tools is an advantage.
• Ability to quickly grasp complex information, assess it professionally, and work precisely and reliably even with an increased workload.
• Independent and goal-oriented way of working as well as enjoyment of working within a team.
• Fluent German and English skills in speaking and writing.
• Proficient use of common MS Office applications.

About this position

• You will become part of our seven-member Plasma & Intermediates Release Management team at the Bern site and report directly to the Group Leader. Together, you will ensure the reliable and quality-compliant release of plasma and intermediates.
• The position is intended with a workload of 60% or three working days per week. Within the framework of our hybrid working model, the activity combines on-site collaboration in Bern with the possibility to perform part of your tasks remotely.
• The focus of your daily work is on the precise technical checking and assessment of information, data, and documents. At the same time, you are in exchange with colleagues on-site and, depending on the topic, also work with international contact persons, including within CSL Plasma.

Do you see yourself in this position? Then we would be happy to receive your CV, your work certificates, and your diplomas as an application.

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.