Scientific Expert QC Excellence LIMS
As a Scientific Expert QC Excellence LIMS at CSL Behring, you will play a crucial role in supporting the Quality Control (QC) department by creating and maintaining master data and providing support to ensure timely batch releases.
You will work with the team in Bern to manage routine changes related to LIMS, leveraging technical skills to continuously improve internal processes and enhance support for business customers. Regular interactions with other departments and global sites will be essential to coordinate the implementation of changes, and facilitate knowledge exchange regarding new requirements and process improvements.
Roles and Responsibilities:
- Manage and maintain LIMS master data and transactional data changes.
- Coordinate and support both local and global changes, and lead process improvement initiatives as the Subject Matter Expert (SME) for LIMS.
- Ensure compliance with current Good Manufacturing Practices (cGMP) and ALCOAA+ requirements in alignment with CSL quality and regulatory commitments.
- Provide first and second-level support for LIMS users and data consumers. Coordinate troubleshooting efforts related to LIMS applications with multiple stakeholders.
- Utilize, maintain, and support the development of QC Excellence internal tools for process and data improvements, using software such as SQL, Python, and Git.
- Act as a mediator between business units and development teams to support the development of new system functionalities.
- Create data extracts using SQL and Power BI.
- Prepare, review, and update Standard Operating Procedures (SOPs), validation documents, and associated documentation. Provide training to LIMS users.
Education and Experience:
- Bachelor’s degree in a relevant scientific or technical discipline (e.g., Natural Sciences, Pharmacy, Computer Science) or an equivalent technical degree in a related field.
- Minimum of 2 years of experience in Quality Control (QC) and/or experience with LIMS.
- Strong technical affinity with a keen interest in data management.
- Experience with programming languages and/or database querying is preferred.
- Familiarity with Good Practice (GxP) regulations is preferred.
- Ability to work independently and collaboratively with local and global teams.
- Proficient in both written and verbal communication in German and English.
Lieu de travail
Wankdorfstrasse 10
3014 Bern
Site web
https://www.cslbehring.ch/careers
