Role Introduction This position executes c GMP QC Bioassay testing, specifically focusing on In Vitro Relative Protein Estimation (IVRPE) for product release and stability. The role is pivotal in maintaining Gx P compliance, supporting method qualifications, and managing technical investigations for non-conforming results (OOS). Core Functions Analytical Execution: Perform routine cell-based assays, including cell culture, transfection, and ELISA-based testing. Data & Systems: Manage sample lifecycles and result entry using LIMS (Lab Vantage) and Electronic Assay Forms. Quality & Compliance: Lead investigations into deviations and CAPAs while ensuring strict adherence to Data Integrity and Good Documentation Practices (GDP). Method Support: Assist in troubleshooting assay methods and equipment, as well as authoring/revising SOPs and technical protocols. Lab Stewardship: Handle reagent preparation, equipment maintenance, and stock management to ensure a safe and efficient working environment. Technical Requirements Education: Technical degree (FP/Ciclo Superior) or University degree in Cell Biology, Biochemistry, or Molecular Biology. Technical Skills: Proven hands-on experience with immunoassays and biological systems under FDA/EU/ICH regulations. Language: Minimum English B2.