Quality Assurance Scientist - Fractionation & Bulk

Innovative and committed to patients worldwide.

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

For our QA Fractionation & Bulk team at the Bern location, we are looking for a committed individual as

Quality Assurance Scientist - Fractionation & Bulk (100%) (m/f/d)

In this role, you are an important Quality Partner for our Fractionation & Bulk Manufacturing areas and work closely with the production teams directly on the shop floor. You support the GMP-compliant execution of our manufacturing processes, accompany deviations and CAPAs, and ensure the quality and compliance of our processes and documentation together with your interfaces.

In addition, you take on QA responsibility in the areas of Batch Record Review, Continuous Process Verification (CPV) and Cleaning Validation, and participate in regulatory topics, audits, inspections, and projects.

Competencies and responsibilities

• You act as a Quality Partner on the floor for our Fractionation & Bulk Manufacturing areas and work closely with the respective production teams.
• You manage deviations and CAPAs, conduct SQUIPP meetings, and prepare the corresponding final QA reports.
• You create, process, and complete measures from deviations, thereby contributing to the implementation of effective Corrective and Preventive Actions and to the reduction of recurring deviations.
• You take over ISA management for topics related to Fractionation & Bulk.
• You review and approve GxP-relevant documents within your area of responsibility and support the implementation and revision of SOPs.
• You ensure an efficient and GMP-compliant Batch Record Review process for Fractionation & Bulk, taking into account regulatory requirements, current industry standards, and internal specifications.
• In the area of Continuous Process Verification (CPV), you take over review and approval of CPV-3b plans, evaluation boards, and reports, including corresponding trend analyses.
• In the area of Cleaning Validation, you review and approve relevant Periodic-Monitoring-Transfer documents for the transition to Phase 3b.
• You ensure compliance with relevant national and international regulatory requirements as well as quality standards within your area of responsibility.
• You review regulatory documents related to your specialist area and support the corresponding communication with authorities.
• You represent your area of responsibility during authority inspections and audits and contribute your QA expertise to the relevant questions.
• You support the monitoring of relevant quality KPIs and participate in the continuous improvement of our processes and working methods.
• You take responsibility for projects and defined project activities within your area of responsibility and ensure their implementation according to the agreed project goals.

Qualifications and professional experience

• Completed Bachelor's degree in a relevant scientific field such as pharmacy, chemistry, biology, or biochemistry.
• Initial professional experience in a cGMP-regulated environment, ideally within the pharmaceutical or biotechnological industry.
• Interest in or initial experience with Quality Assurance in a production environment, particularly in topics such as deviations, CAPAs, GMP documentation, or Batch Record Review.
• Interest in topics such as Continuous Process Verification, Cleaning Validation, and Change Management, as well as the willingness to further expand your knowledge in these areas.
• Good understanding of scientific and technical contexts as well as the ability to quickly familiarize yourself with manufacturing processes and regulatory requirements.
• Strong quality and compliance awareness as well as a careful and structured way of working.
• Analytical thinking skills and a solution-oriented way of working, especially when dealing with deviations and quality-relevant questions.
• Good communication and cooperation skills as well as enjoyment of close cooperation with production and other interdisciplinary interfaces.
• Independent and reliable way of working as well as the ability to coordinate different tasks and priorities in a structured manner.

About this position

• As part of our QA Fractionation & Bulk team, you work closely with our production areas and are regularly present directly on the shop floor.
• This gives you direct insight into our manufacturing processes and allows you to actively contribute as a Quality Partner to ensuring high quality and GMP compliance in the daily production environment.

Do you see yourself in this position? Then we look forward to your application. Please submit your CV, your work references, 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, employ