Descripción del empleo
Role Introduction
This position executes cGMP QC Bioassay testing, specifically focusing on In Vitro Relative Protein Estimation (IVRPE) for product release and stability. The role is pivotal in maintaining GxP 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 (LabVantage) 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.
Información extra
- Status
- Activa
- Estudios requeridos
- E.S.O
- Localización
- Madrid
- Tipo de contrato
- Trabajo estudiantes
- Publicado el
- 16-05-2026
- Carnet de conducir
- No
- Vehículo
- No
- Carta de motivación
- No
- Idiomas
- Español
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