Specialist, Quality Control

Job description

If you’re interested in this role, please apply in English and include an English version of your Resume/CV. The Role: Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients. Moderna is strengthening its international centre for analytical excellence in Madrid, the largest of its kind outside the United States. The site supports our global manufacturing network and advancing mRNA portfolio. We welcome talent ready to drive innovative research and development. Moderna is seeking a technically skilled and digitally minded Quality Control specialist to support the laboratory systems and electronic workflows that underpin analytical excellence across our global QC network. Working across LabVantage LIMS, Chromeleon CDS, SoftMax Pro and Laboratory Execution Systems (LES), you will help ensure that laboratory master data, analytical templates and electronic workflows are accurately configured, effectively maintained and compliant with GMP and data integrity requirements. Based in Madrid and collaborating with QC, Digital and Automation teams internationally, you will have the opportunity to strengthen laboratory performance, advance global standardization and explore emerging digital and AI-enabled technologies that help Moderna deliver innovative mRNA medicines to patients. Here's What You'll Do: Support enterprise QC laboratory systems across Moderna's global network: Provide day-to-day technical and operational support for laboratory informatics platforms, including LabVantage Laboratory Information Management System (LIMS), Thermo Scientific Chromeleon Chromatography Data System (CDS), SoftMax Pro, Laboratory Execution Systems (LES) and other enterprise laboratory applications. Help ensure reliable system performance, effective user support and timely resolution of technical issues that could affect QC laboratory operations. Provide Tier 1 technical support and system troubleshooting: Serve as a first-line support resource for laboratory computerized systems, investigating user-reported issues, identifying potential causes, documenting troubleshooting activities and resolutions, and escalating complex technical problems to Digital, system administrators or other specialist teams as appropriate. Support consistent and effective issue management across laboratory applications and electronic workflows. Maintain and support laboratory system configurations: Perform routine system administration and support activities, including configuration updates, software maintenance and coordination of system installations and upgrades with Digital teams. Contribute to system lifecycle activities and ensure that laboratory applications remain aligned with approved QC business requirements, operational procedures and GMP expectations. Support implementation, testing and deployment of system enhancements: Collaborate with QC, Digital and technical stakeholders to evaluate, test and deploy software updates, configuration changes, system enhancements and new functionality. Help translate laboratory business requirements into practical, scalable system solutions, ensuring that changes are appropriately reviewed, documented and implemented within controlled laboratory environments. Review and maintain LabVantage LIMS master data: Perform detailed technical reviews of master data configured within LabVantage LIMS, verifying accuracy, completeness, consistency and alignment with approved analytical methods, specifications, procedures and business requirements before deployment or operational use. Support the creation, configuration and review of laboratory tests, specifications, sampling requirements, calculations, acceptance limits and other relevant QC master data elements. Develop and review standardized analytical system templates: Create, configure and technically review enterprise laboratory templates within Chromeleon CDS, SoftMax Pro and other applicable analytical platforms. Ensure that template configurations accurately reflect approved analytical methods, scientific requirements and QC workflows, supporting consistent execution, reliable calculations, effective data processing and accurate analytical reporting across laboratories. Troubleshoot and maintain laboratory templates and calculations: Investigate issues associated with system-controlled analytical methods, template configurations, calculation logic, processing parameters, report configurations and related electronic laboratory content. Partner with laboratory subject matter experts, analytical method owners and system teams to identify discrepancies, determine appropriate corrections and maintain reliable, scientifically accurate configurations. Configure and review Laboratory Execution System workflows: Support the creation, configuration and technical review of LES worksheets and electronic laboratory workflows, ensuring that approved procedures and analytical methods are accurately translated into clear, executable laboratory instructions. Verify that electronic workflows support consistent laboratory execution, appropriate data capture and compliance with established QC requirements. Perform detailed technical verification of LES worksheets: Review electronic worksheets for accuracy, procedural sequencing, calculations, data entry and capture requirements, acceptance criteria and alignment with approved source documentation prior to implementation. Work closely with analytical SMEs, laboratory users and system stakeholders to resolve inconsistencies and ensure that electronic instructions faithfully represent approved laboratory processes. Support GMP compliance, data integrity and Quality system activities: Contribute to deviations, change controls, corrective and preventive actions (CAPAs), periodic system reviews and validation documentation associated with laboratory software and electronic workflows. Ensure that system configurations, master data, electronic records and associated processes comply with applicable GMP and GxP regulations, internal procedures and data integrity requirements, including ALCOA+ principles. Maintain accurate, controlled and inspection-ready documentation: Author, revise and maintain equipment, software, business administration and system lifecycle documentation, including Standard Operating Procedures (SOPs), work instructions, technical guidance and training materials. Follow Good Documentation Practices and ensure that laboratory data, configurations, documentation and records are complete, accurate, appropriately maintained and readily available to support audits or regulatory inspections. Execute assigned activities in accordance with approved internal procedures and work instructions. Train and support QC laboratory personnel: Provide practical guidance and training to QC analysts, laboratory users and other stakeholders on laboratory software functionality, system workflows and appropriate system use. Help users understand approved configurations, electronic data capture requirements, troubleshooting approaches and best practices, strengthening confidence and consistency in the use of enterprise laboratory applications. Drive continuous improvement and global standardization: Identify opportunities to simplify laboratory processes, improve system utilization, standardize master data and template configurations, enhance electronic workflows and improve the overall user experience. Collaborate with QC, Digital, Automation and cross-functional teams to implement scalable solutions that reduce manual activities, strengthen data quality and support consistent laboratory operations across Moderna sites. Contribute to digital innovation and AI-enabled QC capabilities: Support the evaluation of emerging digital technologies, automation opportunities and Generative AI-enabled tools that could improve laboratory system support, technical tr