Randstad recruits for its clients and offers temporary staffing, placement and human resources management services.
Analyst, Quality Control, Bioassay, Second Shift
L’analyste réalise des bioessais de contrôle qualité et des tests de stabilité en environnement pharmaceutique cGMP. Il utilise notamment des essais cellulaires, la culture cellulaire, la transfection et les immunoessais, et documente les résultats dans LabVantage LIMS. Le poste est basé à Madrid et s’exerce en équipe d’après-midi, de 14 h à 22 h, sur site.
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The full description published by Randstad.
cGMP QC Bioassay Testing: Execute routine release and stability bioassays¿focused on In Vitro Relative Potency (IVRP)¿in compliance with approved procedures and cGMP standards. Cell Biology & Immunoassays: Perform cell-based assays, cell culture, transfection, and immunoassays (e.g., ELISA) to evaluate biological activity and protein expression. Method Qualification & Acquisition: Support the implementation, technical execution, and qualification of analytical bioassay methods in line with QC protocols.
Troubleshooting & Laboratory Investigations: Help identify root causes and implement corrective actions for technical issues, assay performance anomalies, and Out-of-Specification (OOS) results. Data Management & LabVantage LIMS: Enter, review, and track sample data and Electronic Assay Forms in LabVantage LIMS, ensuring strict data integrity and traceability. Stability Program
Support: Conduct assigned stability testing on schedule and deliver accurate analytical documentation for product quality monitoring. Lab Operations & Inventory Management: Prepare reagents, manage samples, maintain workspace readiness, and monitor supply inventory to prevent testing disruptions. Equipment Maintenance: Perform routine maintenance, monitor instrument performance, and assist in technical troubleshooting with cross-functional teams.
Quality Systems & Continuous Compliance: Contribute to quality events, deviation investigations, Change Controls, and CAPAs in accordance with cGMP expectations. Controlled Documentation: Author, review, and maintain SOPs, analytical protocols, and technical reports adhering to Good Documentation Practices (GDP). GxP, Data Integrity & Safety: Maintain strict adherence to GxP regulations, biosafety standards, safe handling of biological materials, and audit readiness.
Second Shift Operations (14:00¿22:00): Maintain testing schedules, coordinate smooth shift handovers, and ensure uninterrupted QC laboratory workflow. Continuous Improvement & Digital Innovation: Identify process optimizations and adopt approved digital tools, automation, and emerging AI capabilities within GMP and data security frameworks. Requisitos del puesto: Technical qualification (FP, ciclo superior) or degree in Cell Biology, Molecular Biology, Biochemistry, or other relevant scientific discipline with at least 2 years¿ experience Working experience: minimum 2 years¿ experience in quality control laboratory of a pharmaceutical company is preferred.
Hands-on experience with cell-based assays and biological systems, cell culture, transfection, ELISA or other immunoassays. Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations preferred. Ability to collaborate effectively in a dynamic, cross-functional matrix environment. Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment. Proficiency in English (verbal and/or written) required due to global collaboration needs.
Formación: Licenciado : Bioquímica , Grado : Grado en Biología Idiomas: Inglés : B2 Conocimientos: experience with cell-based assays and biological systems, cell culture , elisa or other immunoassays , knowledge of relevant and current fda, eu, ich guidelines and regulations Experiencia: 2 años Tus beneficios: Joining a large, growing multinational company Salary: 35,000 Schedule: fixed afternoon shift, from 2:00 PM to 10:00 PM This role is 100% onsite, reflecting the importance of being physically present to support the work, collaborate closely with colleagues, and contribute to our site-based operations.
Requirements
- Qualification technique (FP, cycle supérieur) ou diplôme en biologie cellulaire, biologie moléculaire, biochimie ou disc
- Au moins 2 ans d’expérience dans un laboratoire de contrôle qualité pharmaceutique
- Expérience pratique des essais cellulaires et systèmes biologiques, de la culture cellulaire, de la transfection, de l’E
- Connaissance pratique souhaitée des directives et réglementations FDA, UE et ICH en vigueur
- Capacité à collaborer efficacement dans un environnement matriciel dynamique et transversal
- Capacité à hiérarchiser et mener à bien plusieurs projets et tâches dans un environnement exigeant
- Maîtrise de l’anglais requise
Benefits mentioned
- Intégration dans une grande entreprise multinationale en croissance
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