QC Analyst 2, One-Year Contract

As a QC Analyst 2 in FBC Quality QC Release & Stability Biological Testing, you ensure reliable analytical results through careful sample handling, proper use of laboratory equipment and complete documentation. The role focuses on cell-based testing of new medicines for release and stability studies for local and international partners.

• Carry out analytical testing of biological medicines, including active ingredients and finished products, according to specified methods and GMP requirements
• Analyze, assess, compare against specifications, review and double-check results, and identify, report and document results outside specifications, trends and deviations
• Document all activities in line with GMP and enter and review data in SAP and LIMS
• Carry out analytical method transfers and handle change controls, deviations and OOX/LI processes, including laboratory and special investigations
• Look after laboratory equipment and systems, perform calibrations and qualifications, and ensure equipment meets requirements
• Contribute to corrective and preventive actions, standard operating procedures, continuous improvement projects and other project activities, and support inspections
• Ensure compliance with cGMP, health, safety and environmental requirements and workplace safety rules, and train colleagues, apprentices and working students

• Analytical knowledge of testing medicines and starting materials using cell-based methods (bioassays), or experience culturing human cell lines, is desirable
• Good knowledge and practical application of cGMP requirements
• Basic knowledge of the regulatory requirements in this field
• SAP experience is desirable
• Ability to act responsibly and work well in a team
• Ability and willingness to communicate with colleagues, managers, customers and suppliers
• Confidence to actively provide feedback within the organizational unit
• Training: Technical or scientific vocational training leading to a laboratory technician qualification in biology, or alternatively chemistry
• Languages: Good written and spoken German and English