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Sr. Specialist, Quality Control, Chemistry

Moderna

Madrid, SpainSenior
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Location
Madrid, Spain
Work model
On-Site
Level
Senior
Posted

About this role

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 an experienced Quality Control Chemistry professional to play a critical role in ensuring the scientific integrity, accuracy and cGMP compliance of analytical data supporting product release and stability testing at our Madrid laboratory. Combining advanced analytical expertise with ownership of Quality Events and hands-on laboratory support, you will oversee complex data reviews, lead investigations and drive timely resolution of technical and compliance challenges. As a senior QC representative on our 2:00–10:00 pm evening shift, you will also provide cross-functional technical and operational leadership, enabling real-time decision-making, effective risk escalation and continuity of laboratory operations while supporting the delivery of Moderna's innovative mRNA medicines. Here's What You'll Do: Ensure scientific excellence in analytical data review and product release: Perform comprehensive review and approval of executed analytical assay packages supporting cGMP product release and stability testing, including both paper-based and electronic records. Evaluate chromatography data, analytical calculations, instrument outputs and other laboratory results to verify scientific accuracy, data integrity, compliance with approved analytical methods and adherence to applicable cGMP requirements. Provide technical expertise across advanced analytical chemistry techniques: Apply strong scientific judgment when reviewing analytical data generated through High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), spectroscopic and spectrometric techniques, and physical property testing. Support the evaluation of analytical results involving Dynamic Light Scattering (DLS) for particle analysis, break-loose/gliding force testing, Container Closure Integrity Testing (CCIT) and other relevant analytical methodologies, ensuring results are reliable, appropriately documented and suitable for their intended Quality Control purpose. Drive Quality Event investigations and timely resolution: Initiate, lead, coordinate and investigate laboratory-related Quality Events, including deviations, Out-of-Specification (OOS) results, laboratory investigations and associated Quality records. Apply structured problem-solving and technical expertise to identify potential root causes, assess product and compliance impact, define appropriate corrective actions and ensure investigations are completed accurately and within required timelines. Own corrective actions and controlled Quality improvements: Define, implement and monitor actions arising from laboratory investigations and Quality Events, supporting or owning Corrective and Preventive Actions (CAPAs) as applicable. Initiate and manage Change Controls within your area of responsibility, ensuring that proposed changes are appropriately assessed, documented and implemented in accordance with established Quality systems and cGMP expectations. Provide senior technical and operational leadership during the evening shift: Act as a key QC representative during the 2:00–10:00 pm shift, providing technical guidance and operational coordination across Chemistry and other QC disciplines. Support real-time decision-making, issue escalation, workload prioritization and cross-functional problem-solving to maintain continuity of laboratory operations, address emerging

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