Specialist, Quality Control

About This Role

This individual contributor role supports cGMP QC testing of raw materials, drug substance, and finished products at Moderna's manufacturing facility and affiliated contract organizations. It combines hands-on analytical testing and troubleshooting with leadership of method transfers, qualification activities, and quality records. You will teach and train analysts, collaborate across Manufacturing, Quality Assurance, and Development, and help strengthen the technical capabilities of a safe, compliant QC Bioassay laboratory.

Responsibilities

• Execute testing for analytical method validation and qualification, alongside routine testing of release, stability, and in-process samples, using cell-based potency assays, enzyme-linked immunosorbent assays (ELISA), and protein analysis
• Execute QC molecular biology and bioassay methods, including qPCR, sequencing, and protein analysis, and support bioassay testing for raw materials, drug substance, and drug product
• Lead method transfers and qualification activities in collaboration with Development groups, helping expand QC Bioassay laboratory capabilities and establish methods that support reliable cGMP testing
• Lead special projects as a Bioassay subject matter expert (SME), bringing technical expertise to laboratory challenges
• Serve as an interdepartmental liaison to Manufacturing, Quality Assurance, Development, and other relevant groups
• Teach and train analysts on technical concepts and analytical methods, providing on-the-job training that builds understanding of laboratory procedures and assay execution
• Write and revise standard operating procedures (SOPs), protocols, and reports, ensuring compliance with cGMP documentation requirements and applicable regulatory guidelines
• Troubleshoot analytical methods, equipment, laboratory procedures, and assay performance, applying technical understanding to identify issues and support effective resolution
• Review analytical data and perform assigned data analysis and trending to support understanding of assay performance and laboratory results
• Own and manage quality records, including investigations, change controls, corrective and preventive actions (CAPAs), and ECs, ensuring that associated activities and documentation meet cGMP requirements
• Establish and maintain a safe laboratory working environment, provide support during audits, and collaborate on continuous improvement initiatives
• Explore opportunities to build familiarity with Generative AI tools for technical learning, knowledge sharing, and continuous improvement, subject to company approval and appropriate data protection, scientific oversight, and cGMP controls
• Remain accountable for completing all mandatory training and assigned tasks, and perform additional duties as assigned

Requirements