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Quality Control Associate, Sample Management
As an individual contributor within QC Sample Management, you will ensure end-to-end sample governance, integrity, and regulatory compliance across internal teams, testing laboratories, and CMO partners: End-to-End Sample Lifecycle: Lead the intake, processing, tracking, storage, transfer, and disposition of Chemistry, Microbiology, and Bioassay samples, ad…
Datos sobre Randstad
- Dominio oficial
- randstad.es
- Ofertas abiertas
- 6234
Detalles de la oferta
La descripción completa publicada por Randstad.
As an individual contributor within QC Sample Management, you will ensure end-to-end sample governance, integrity, and regulatory compliance across internal teams, testing laboratories, and CMO partners: End-to-End Sample Lifecycle: Lead the intake, processing, tracking, storage, transfer, and disposition of Chemistry, Microbiology, and Bioassay samples, adhering strictly to GMP, Good Documentation Practices (GDP), and Data Integrity standards.
Stability Program Ownership: Manage the complete stability-sample lifecycle in compliance with approved protocols, overseeing inventory tracking, reconciliations, and precise scheduled pull-outs to ensure timely delivery for testing. Operational Coordination & Stakeholder Alignment: Partner closely with internal departments, external laboratories, and CMOs to align testing priorities, analytical requirements, and schedules while resolving operational bottlenecks.
Quality Systems & Investigations: Provide technical and operational input for deviations, CAPAs, and change controls related to sample management workflows. Digital Excellence & Process Innovation: Collaborate with the Digital team to enhance LIMS capabilities and workflows; identify opportunities to integrate Generative AI and other digital tools to streamline QC operations and data insights.
Laboratory Operations & Controlled Storage: Support general laboratory housekeeping, coordinate maintenance, and resolve operational issues with controlled-temperature units (freezers, incubators, chambers) to ensure continuous sample safety. Requisitos del puesto: Education: Technical scientific diploma (Vocational Training / Higher Degree) or Bachelor¿s degree in Chemistry, Biology, Pharmacy, or a related scientific discipline.
Experience: Minimum of 2 years of hands-on Quality Control laboratory experience within the pharmaceutical or biotechnology industry, specifically in GMP environments. Regulatory Knowledge: Familiarity with FDA, EU/EMA, and ICH guidelines, accompanied by strong knowledge of GxP and Data Integrity principles (preferred). Languages: Minimum B2 English proficiency (professional working proficiency for daily collaboration across global teams). Core Competencies: Ownership mindset, digital affinity, strong multitasking skills, structured prioritization, and effective cross-functional communication.
Working Model: 100% onsite presence at the Madrid facility. Formación: Licenciado : Bioquímica , Grado : Grado en Biología Idiomas: Inglés : B2 Conocimientos: Normativa GMP Experiencia: 2 años Tus beneficios: Global Health Impact: Directly support groundbreaking mRNA programs that deliver life-changing medicines to patients worldwide. Flagship Analytical Facility: Accelerate your career within a world-class, technologically advanced QC excellence hub in Madrid.
Digital-First Culture: Work in a forward-thinking environment actively investing in state-of-the-art LIMS platforms and artificial intelligence integration. Dynamic Onsite Collaboration: An in-person environment offering real-time problem-solving, hands-on mentorship, and cross-functional team synergy.
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