Specialist, Quality Control

Reporting to the Senior Manager/Manager of QC Sample Management, you will serve as a subject matter expert supporting Chemistry operations within Moderna's Quality Control organization in Marlborough. As an individual contributor, you will provide technical and functional leadership across cGMP sample coordination, Chemistry testing, laboratory operations, quality systems, and cross-functional partnerships with internal and external laboratories, while remaining closely connected to hands-on laboratory work. Working Monday through Friday, you will help strengthen safe, compliant, efficient QC operations while advancing digital laboratory capabilities, including opportunities to work closely with LIMS, data-driven workflows, and emerging Generative AI tools that can support scientific and operational excellence.

Here's What You'll Do

• Provide technical and functional leadership to associates supporting QC Chemistry and various Development laboratories, while operating as an individual contributor rather than a direct people manager.
• Oversee laboratory and sample-management schedules to support the safe and timely completion of sample processing, Chemistry testing, data review, and associated quality records.
• Apply strong knowledge of HPLC testing and chromatogram analysis to support Chemistry operations, data interpretation, troubleshooting, and compliant execution of laboratory activities.
• Contribute directly to hands-on laboratory work while serving as a subject matter expert for cGMP sample coordination and testing activities.
• Coordinate cGMP samples and associated testing activities across internal teams and external laboratories, ensuring appropriate communication, traceability, compliance, and execution.
• Author and revise SOPs, protocols, and other controlled documentation required to support QC Chemistry and Sample Management operations.
• Author, investigate, and support quality-system records, including deviations, CAPAs, and change controls, ensuring issues are appropriately documented, assessed, and driven to resolution.
• Partner with Moderna's Digital team to expand and optimize the use of the LabVantage LIMS platform, strengthening laboratory workflows, data integrity, traceability, and operational efficiency.
• Explore opportunities to work alongside Digital partners and emerging Generative AI-enabled tools to improve knowledge access, laboratory workflows, documentation, data review, and operational decision-making where appropriate within regulated processes.
• Collaborate with Quality Control teams to continuously improve the quality, compliance, efficiency, and scalability of QC operations.
• Provide subject matter expertise and operational support during internal and external audits, helping ensure laboratory activities, records, systems, and processes remain inspection-ready.
• Manage controlled temperature units (CTUs), including oversight, maintenance coordination, monitoring, and troubleshooting to support reliable sample and material storage.
• Lead technical troubleshooting and provide guidance and support to the Sample Management team when laboratory, operational, or compliance issues arise.
• Establish and maintain a safe laboratory working environment, reinforcing safe laboratory practices and appropriate execution of regulated activities.
• Support review of analytical and laboratory data and the generation of Certificates of Analysis (COAs), ensuring records are accurate, complete, and compliant with applicable quality requirements.
• Work cross-functionally with QC, Development, Digital, Quality, and internal and external laboratory partners to enable effective Chemistry operations and timely testing.

Here's What You'll Need (Basic Qualifications)

• BA/BS in a relevant scientific discipline with a minimum of 2-5 years (or MS in a relevant scientific discipline with a minimum of 0-3 years) Quality Control experience in a cGMP organization
• Demonstrate ability to effectively and independently prioritize, manage, and complete multiple projects and tasks in a fast-paced environment
• Detailed knowledge of LIMS system (LIMS) and quality document system (Veeva)
• Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations
• Experience with gowning, aseptic technique and general lab safety practices
• Flexible schedule to support periodic on call, weekend or holiday coverage
• Strong and effective people management skills