Sr. Specialist, Sample Management
Publicado en 2026-10-02
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Control de Calidad
Analista de cumplimiento, Gerente de Calidad, Especialista de Gestión de Calidad
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.
Reporting to the Manager of Quality Control Operations, you will take ownership of end-to-end QC Sample Management, helping ensure Chemistry, Microbiology and Bioassay samples move safely, accurately and efficiently across Moderna and its external manufacturing network.
As an individual contributor and subject matter expert for Sample Management, you will connect QC laboratories, External QC, Regulatory, Operations, Manufacturing, Quality Assurance, Supply Chain and CMO partners, translating complex sample requirements into coordinated execution while maintaining rigorous cGMP standards. This is a highly hands‑on opportunity to combine laboratory operations, quality systems, controlled‑temperature unit management and digital innovation, including partnering with Digital colleagues to optimize LIMS and gaining exposure to Generative AI tools that can support the evolution of QC operations.
Here’sWhat You’ll Do:
Define, implement and maintain an end-to-end sample management process for QC Chemistry, Microbiology and Bioassay samples received internally from Moderna sites and from CMO sites.
Serve as a key point of contact and subject matter expert for Sample Management, partnering cross‑functionally with QC laboratories, External QC, Regulatory, Operations, Manufacturing, Quality Assurance, Supply Chain and CMO partners to align sample‑related activities, priorities, requirements and timelines.
Coordinate and facilitate the cross‑functional resolution of sample management issues, ensuring appropriate communication, escalation and follow‑up with relevant stakeholders.
Monitor and ensure the safe and timely execution of daily sample processing activities and accurate completion of associated quality records.
Author and revise SOPs, protocols and quality system records, including deviations, CAPAs and change controls.
Create weekly sample management schedules and run periodic alignment meetings with internal stakeholders and external partners as required.
Partner with the Digital team to expand and optimize the use of the LIMS system, while exploring opportunities to get closer to Generative AI tools and emerging digital capabilities that can further enhance QC workflows, knowledge and operational efficiency.
Work closely with Quality Control laboratory teams to continuously improve the quality, compliance and efficiency of laboratory sample operations.
Provide support to audit teams during internal and external audits.
Perform general laboratory support activities as required, including housekeeping.
Manage controlled‑temperature units, including their maintenance and troubleshooting.
Lead troubleshooting activities and provide guidance and support to the sample management process when compliance issues arise.
Train colleagues, oversee team training assignments and help ensure compliance requirements remain current.
Establish and maintain a safe laboratory working environment.
Foster a positive and inclusive working culture that promotes collaboration, innovation and continuous improvement.
Follow all relevant GxP regulations, guidelines and company policies to ensure compliance with regulatory and internal requirements.
Execute tasks precisely as defined in internal guiding documents, including standard operating procedures and…
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