Senior Specialist, Quality Control, Laboratory Systems

hace 1 semana


Madrid, España Moderna A tiempo completo

Senior Specialist, Quality Control, Laboratory Systems Moderna Madrid, Community of Madrid, Spain Moderna offers a unique opportunity to join a pioneering team that is revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases. Role Overview This site‑based, individual contributor role focuses on supporting all digital systems in Moderna’s Quality Control laboratories. Acting as a bridge between QC and Digital teams, you will enable seamless operation and compliance of laboratory systems, configure and deploy critical digital platforms, and ensure adherence to global regulatory standards. It is a high‑impact position at the convergence of QC operations, digital innovation, and compliance, offering the opportunity to work with cutting‑edge tools and generative AI platforms. Key Responsibilities Provide ongoing digital support for all laboratory computer systems in QC. Collaborate with Digital and QC teams to install, configure, and maintain standalone lab systems. Act as the primary liaison between Digital and QC to support business and operational needs. Own and manage quality system records—such as deviations, CAPAs, and change controls—related to QC software systems. Support method troubleshooting, remediation initiatives, and system optimization projects in cross‑functional teams. Author or revise SOPs related to equipment, software, and QC methodologies. Deliver training to QC personnel on lab system software. Participate in cross‑functional process improvement projects that enhance QC digital infrastructure. Ensure documentation is completed in accordance with cGMP and regulatory requirements. Follow all GxP guidelines, internal SOPs, and Good Documentation Practices to maintain data integrity and audit readiness. Required Qualifications BS in a relevant scientific discipline (Science, Engineering, or Business). +5 years of experience in a quality control laboratory of a pharmaceutical company (preferred). Experience in a GMP environment. Working knowledge of FDA, EU, ICH guidelines and regulations. Ability to collaborate effectively in a dynamic, cross‑functional matrix environment. Strong prioritization and multitasking skills in a fast‑paced environment. Site‑based position; remote work is not eligible. Benefits Quality healthcare and insurance benefits. Lifestyle Spending Accounts for well‑being. Free premium access to fitness, nutrition, and mindfulness classes. Family planning and adoption benefits. Generous paid time off, including vacation,



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