M

Moderna

Develops mRNA-based medicines for health

Quality Control Specialist

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

About the Job

Requirements

  • A Bachelor of Science in Sciences or a relevant scientific field is required.
  • Three to five years of experience in the biotechnology or biopharmaceutical industry, preferably in a quality control laboratory, laboratory systems, digital, or automation role.
  • Strong problem-solving skills and the ability to troubleshoot artificial intelligence-related quality control processes are required.
  • Proficiency in English, verbal and/or written, is required for global collaboration.
  • Understanding of quality control laboratory workflows, analytical methods, specifications, data review, and translating approved laboratory procedures into electronic system configurations.
  • Ability to work across functions and communicate technical issues effectively.

Responsibilities

  • Provide day-to-day technical and operational support for enterprise quality control laboratory systems, 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; support reliable performance, users, and timely issue resolution.
  • Provide Tier 1 support for computerized laboratory systems by investigating reported issues, identifying potential causes, documenting troubleshooting and resolutions, and escalating complex problems to appropriate teams.
  • Perform routine system administration and support, including configuration updates and software maintenance, and coordinate installations and upgrades with Digital teams; contribute to system lifecycle activities and keep applications aligned with approved business requirements, procedures, and Good Manufacturing Practice (GMP) expectations.
  • Collaborate with quality control, Digital, and technical stakeholders to evaluate, test, and deploy software updates, configuration changes, enhancements, and new functionality; translate laboratory business requirements into scalable system solutions and document and implement changes in controlled environments.
  • Review LabVantage LIMS master data for accuracy, completeness, consistency, and alignment with approved methods, specifications, procedures, and requirements; support configuration and review of tests, specifications, sampling requirements, calculations, acceptance limits, and other master data.
  • Create, configure, and technically review enterprise laboratory templates in Chromeleon CDS, SoftMax Pro, and other analytical platforms to reflect approved methods, scientific requirements, and workflows, and support consistent execution, calculations, data processing, and reporting.
  • Investigate issues with system-controlled analytical methods, templates, calculation logic, processing parameters, report configurations, and other electronic laboratory content; partner with subject matter experts, method owners, and system teams to determine corrections and maintain accurate configurations.
  • Support the creation, configuration, and technical review of Laboratory Execution System worksheets and electronic workflows, translating approved procedures and methods into clear, executable instructions that support consistent execution, appropriate data capture, and quality control requirements.
  • Review electronic worksheets for accuracy, procedural sequencing, calculations, data-entry and capture requirements, acceptance criteria, and consistency with approved source documentation; resolve inconsistencies with subject matter experts, laboratory users, and system stakeholders.
  • Contribute to deviations, change controls, corrective and preventive actions, periodic system reviews, and validation documentation for laboratory software and electronic workflows; ensure configurations, master data, electronic records, and processes comply with applicable GMP and GxP regulations, internal procedures, and data integrity requirements, including ALCOA+ principles.
  • 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 maintain complete and inspection-ready records in accordance with approved procedures.
  • Provide practical guidance and training to quality control analysts, laboratory users, and stakeholders on laboratory software, workflows, appropriate system use, electronic data capture, troubleshooting, and best practices.
  • Identify opportunities to simplify laboratory processes, improve system use, standardize master data and templates, enhance electronic workflows, and improve user experience; collaborate across quality control, Digital, Automation, and other teams to implement scalable solutions that reduce manual work and strengthen data quality.
  • Support evaluation of emerging digital technologies, automation opportunities, and Generative AI-enabled tools for system support, troubleshooting, knowledge management, and workflow efficiency; work with Digital and Quality stakeholders to explore solutions while maintaining GMP compliance, data integrity, and system governance.
  • Collaborate with quality control laboratories, analytical method owners, Digital, Automation, and other international stakeholders to translate laboratory requirements into reliable configurations, communicate technical issues, and develop standardized and sustainable digital laboratory processes.

Desired Qualifications

  • Experience working in a GMP-regulated environment is preferred.
  • Experience with laboratory informatics systems such as LIMS and Chromatography Data Systems is a plus.
  • Hands-on experience with laboratory informatics and enterprise systems such as LabVantage LIMS, Chromeleon CDS, SoftMax Pro, and/or Laboratory Execution Systems (LES) is strongly preferred.
  • Experience creating, configuring, or reviewing laboratory master data, analytical system templates, electronic worksheets, calculations, or other system-controlled laboratory content is preferred.

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

Recently Posted Jobs

Explore more opportunities at Moderna

See more jobs