Quality Control Associate, Bioassay

Quality Control Associate, Bioassay

Moderna

Madrid, Spain

Join our Quality Control Bioassay team and play a critical role in ensuring the quality, safety, and consistency of Moderna’s innovative mRNA medicines. In this laboratory-based individual contributor role, you will perform cGMP QC testing supporting In Vitro Relative Protein Expression (IVRPE), release and stability testing, while contributing to method qualification, continuous improvement, and operational excellence.

Working in a highly regulated GMP environment, you will combine strong scientific expertise with rigorous quality standards to generate reliable analytical data that supports product release and long-term stability. You will also have opportunities to work alongside digital and Generative AI-enabled tools that continue to enhance laboratory operations, data analysis, and scientific decision-making across Moderna.

Here's What You'll Do:

• Perform cGMP Quality Control Bioassay testing with a focus on In Vitro Relative Protein Expression (IVRPE), supporting release and stability programs.
• Support Method Qualification and Acquisition activities as required.
• Perform routine analytical bioassay testing supporting Cell Biology, including ELISA methodologies.
• Execute analytical testing accurately and in accordance with approved procedures and regulatory requirements.
• Perform general laboratory support activities including reagent preparation, sample management, equipment maintenance, laboratory housekeeping, and ensuring laboratory readiness.
• Perform LIMS (LabVantage) sample result entry and execute Electronic Assay Forms within LIMS.
• Support stability programs through timely testing and documentation.
• Perform data entry and contribute to data trending activities.
• Manage and maintain QC laboratory supplies and inventory.
• Assist with troubleshooting analytical methods and laboratory equipment where required.
• Support investigations related to Out of Specification (OOS) results and other non-conforming events.
• Participate in quality systems activities including investigations, deviations, change controls, and CAPAs.
• Write, revise, and maintain Standard Operating Procedures (SOPs), protocols, technical reports, and other controlled documentation.
• Complete and maintain accurate cGMP documentation for all work performed.
• Execute work precisely in accordance with Standard Operating Procedures (SOPs), work instructions, and other internal guiding documents.
• Follow Good Documentation Practices and Data Integrity requirements to ensure records are accurate, complete, and inspection-ready.
• Ensure compliance with all applicable GxP regulations, internal policies, and regulatory expectations.
• Establish and maintain a safe laboratory working environment while promoting a culture of quality, compliance, and continuous improvement.

Here’s What You’ll Need (Basic Qualifications):

• Technical qualification (FP, ciclo superior) or degree in Cell Biology, Molecular Biology, Biochemistry, or other relevant scientific discipline with at least 2 years’ experience.
• Working experience: minimum 2 years’ experience in quality control laboratory of a pharmaceutical company is preferred.
• Hands-on experience with cell-based assays and biological systems, cell culture, transfection, ELISA or other immunoassays.
• Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations preferred.
• Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
• Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment.
• Working proficiency in English, minimum B2 level required.