QC Specialist (m/f/d)

Key Responsibilities: Perform bioanalytical release and stability testing in compliance with cGxP and data integrity requirements. Prepare, evaluate, and report on project-related protocols, plans, trend analyses, and testing activities. Implement new product testing into the routine laboratory and support method development and validation activities. Manage analytical weak points, perform complex troubleshooting, and support continuous improvement of laboratory workflows. Review analytical data and tests, including analytical release activities, to ensure accuracy, quality, and compliance. Handle OOx results and deviations, define CAPAs, and contribute to effective investigation processes. Maintain and calibrate laboratory equipment, including preparation of maintenance and calibration plans. Act as SPoC or SME for bioanalytics initiatives and contribute to relevant documentation workflows and technical authoring. Support sample planning, sampling execution, supplier qualification, and KPI/KQI trending and analysis. Follow all HSE guidelines, proactively identify and report potential risks, propose solutions, and participate in required trainings.