QA Scientist - Product Release

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, with over 1'500 employees, we develop and produce life-saving therapies for people with serious and rare diseases worldwide.

For our QA Batch Release team within our Quality Management, we are looking for a dedicated individual as

QA Scientist - Product Release (100%) (m/f/d)

In this scientific Quality Assurance role, you will contribute to the GMP-compliant and timely release of our end products, thereby ensuring that our high quality standards as well as the relevant regulatory requirements are met.

In addition to operational product release, you will support the maintenance and further development of our release processes, participate in the introduction of products into new markets, and support your team during audits, inspections, and internal projects. In doing so, you will work in a regulated environment and be in exchange with various internal interfaces as well as in the environment of national and international health authorities.

Competencies and Responsibilities

• GMP-compliant and timely release of end products according to applicable cGMP requirements, regulatory specifications, and SOPs.
• Creation, review, and updating of SOPs and specifications within the area of responsibility.
• Support in the introduction of new and existing products into new markets, taking into account the relevant quality and regulatory requirements.
• Participation in the maintenance and further development of an efficient and GMP-compliant release system.
• Support in the preparation and execution of regulatory audits and inspections in the product release area.
• Participation in department-internal projects and assumption of defined tasks within the respective project scope.
• Support in the continuous optimization of business and quality processes within the area of responsibility.

Qualifications and Professional Experience

• Completed Master's degree in pharmacy, biology, chemistry, or a comparable scientific field, or an equivalent qualification.
• Initial professional experience in the pharmaceutical industry and/or a GMP-regulated environment is an advantage.
• Knowledge of Good Manufacturing Practices (GMP) as well as interest in Quality Assurance and Product Release.
• Strong analytical and networked thinking skills as well as a careful and structured way of working.
• Independent, proactive, and solution-oriented way of working as well as enjoyment of working in a team-oriented environment.
• Open and professional communication style when dealing with different internal and external interfaces.
• Very good German and English skills, both written and spoken.
• Confident handling of MS Office; experience with relevant quality systems is an advantage.

About this position

• As part of our QA Batch Release team, you will contribute directly to ensuring the quality and GMP-compliant release of our end products.
• In doing so, you will gain a broad insight into product release, regulatory requirements, and the associated quality systems and will work closely with experienced colleagues as well as various internal interfaces.

Do you see yourself in this position? Then we look forward to your application. Please submit your CV, your work certificates, and your diplomas together as one file.

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.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.