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Moderna

Develops mRNA-based medicines for health

Quality Control Senior Specialist - Quality Control

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeMadrid, SpainNo salary listed

About the Job

Requirements

  • A Bachelor of Science or Master of Science in sciences or a relevant scientific field.
  • A bachelor's degree in sciences and 5–8 years of industry experience, or preferably a master's degree in sciences and 3–6 years of industry experience.
  • Demonstrated advanced hands-on experience with Thermo Scientific Chromeleon Chromatography Data System, including creation, configuration, review, and troubleshooting of HPLC instrument methods, processing methods, sequences, and report templates.
  • Strong practical knowledge of HPLC/UPLC workflows, chromatographic data processing, peak integration, system suitability, calculations, and analytical data review.
  • Proven ability to build and troubleshoot complex Chromeleon report templates and calculations and translate analytical method requirements into standardized CDS configurations.
  • Proficiency in English, verbal and/or written, is required for global collaboration.

Responsibilities

  • Serve as a global subject matter expert for Thermo Scientific Chromeleon, providing advanced technical expertise to QC laboratories across the global network and supporting chromatography workflows, system functionality, HPLC/UPLC method configuration, chromatographic data acquisition, processing, integration, calculations, and reporting.
  • Design, configure, and maintain standardized Chromeleon workflows for HPLC analytical workflows, including instrument methods, processing methods, analytical sequences, electronic workflows, and report templates; translate approved analytical method requirements into reliable CDS configurations for consistent analytical execution, processing, calculations, review, and reporting across multiple QC laboratories.
  • Develop, configure, and optimize complex Chromeleon report templates with calculations, variables, custom fields, tables, chromatograms, system suitability results, specifications, and other critical report elements, ensuring accurate outputs aligned with approved methodologies and regulatory requirements while minimizing manual intervention.
  • Configure and optimize Chromeleon processing methods, peak integration parameters, calculation logic, and standardized integration approaches, applying chromatographic principles, HPLC/UPLC workflows, system suitability, and analytical data interpretation to produce consistent, scientifically justified, and reproducible results.
  • Investigate and resolve complex technical issues involving chromatographic data acquisition, processing, peak integration, calculations, report generation, sequence execution, instrument connectivity, and user workflows; partner with analytical method owners, laboratory analysts, and technical subject matter experts to diagnose and resolve template behavior, calculation discrepancies, processing anomalies, and reporting defects.
  • Review instrument methods, processing methods, report templates, and related workflows for accuracy, consistency, usability, and alignment with approved analytical methods and QC requirements; identify configuration weaknesses, calculation errors, and reporting inconsistencies and implement improvements.
  • Collaborate with QC laboratories and analytical method owners across sites to harmonize Chromeleon templates, reporting standards, and chromatography workflows; identify opportunities to reduce manual transcription, simplify analytical execution and review, improve data integrity, and increase operational efficiency while retaining method-specific flexibility.
  • Provide technical expertise for qualification, validation, change control, and implementation of new or revised Chromeleon methods, templates, reports, and configurations; ensure changes are assessed, tested, documented, and deployed within a controlled cGMP environment in alignment with approved analytical requirements, internal procedures, and regulatory expectations.
  • Work with Digital, system administration, and laboratory stakeholders on Chromeleon system configuration, upgrades, testing, technical issue resolution, and enhancements, contributing QC expertise to system lifecycle activities and evolving analytical, operational, and compliance needs.
  • Ensure Chromeleon configurations, electronic workflows, and associated QC processes comply with applicable current Good Manufacturing Practice requirements, data integrity expectations, internal Quality procedures, and regulatory standards; support accurate, traceable, and reliable electronic data processing and reporting.
  • Provide technical input into investigations, deviations, corrective and preventive actions, and change controls involving Chromeleon functionality, HPLC data workflows, method and template configurations, calculations, or reporting; identify root causes, assess potential impacts, and implement sustainable corrective solutions.
  • Author, review, and revise Standard Operating Procedures, work instructions, technical standards, training materials, and supporting documentation related to Chromeleon, chromatography template configuration, data review, and troubleshooting; provide hands-on technical guidance, coaching, and software training to QC analysts and reviewers.
  • Identify opportunities to use automation, digital technologies, and Generative AI-enabled tools to improve technical knowledge sharing, documentation efficiency, troubleshooting workflows, and analytical process standardization; partner with Digital and Quality stakeholders to explore these within validation, data integrity, information security, and cGMP frameworks.
  • Collaborate as an expert individual contributor with QC laboratory teams, analytical subject matter experts, Quality functions, Digital specialists, and system administrators across the international network; translate complex technical requirements into practical solutions, share best practices, and support consistent implementation of standardized Chromeleon workflows across sites.

Desired Qualifications

  • A master's degree in sciences and 3–6 years of industry experience is preferred over the bachelor's-degree pathway.

About the Company

Moderna

Develops mRNA-based medicines for health

Moderna develops medicines built on messenger RNA (mRNA). Its products use mRNA delivered into cells to instruct them to produce specific proteins that can prevent or treat disease, with vaccines being a primary example. In practice, a dose delivers engineered mRNA into the body, cells translate it into a target protein, and the immune system responds or the protein modulates biology to combat disease. Moderna differentiates itself through its focus on building a whole mRNA medicines platform and in-house capabilities for designing, manufacturing, and scaling mRNA therapies, including rapid development and large-scale production. Its goal is to create a new category of medicines based on mRNA that can improve how diseases are discovered, developed, and treated, ultimately improving patient outcomes.

Company size
5,001-10,000
Company stage
IPO
Headquarters
Cambridge, MA
Founded
2010

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