Associate I, Quality Control Microbiology EMCU

Moderna • Norwood, MA

10d • Onsite

About The Position

Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients. Moderna is strengthening its presence in Norwood, Massachusetts, a cornerstone of our manufacturing and operational excellence. Our Norwood campus translates mRNA science into scalable impact, supporting the global delivery of our medicines. We welcome talent ready to drive innovation and make a meaningful difference for patients worldwide. In this role, you will execute critical environmental monitoring and utility sampling that directly supports the integrity of GMP manufacturing operations. You will serve as a key quality partner across clinical and commercial production, ensuring sterility assurance through precise, compliant laboratory practices. This individual contributor role offers the opportunity to deepen microbiological expertise while leveraging digital systems and gaining exposure to advanced data and AI-enabled technologies.

Requirements

• STEM degree with 0+ years’ of experience in a GMP QC laboratory setting, focusing on microbiology.

Nice To Haves

• Hands-on experience with particle counters, viable air samplers, and gas equipment.
• Proficiency with Microsoft Office Programs and electronic databases (LIMS, SAP, eQMS).
• Excellent troubleshooting skills and the ability to communicate scientific issues clearly.
• Strong written and oral communication skills and organizational abilities.
• Knowledge of GMP, microbiology, aseptic techniques, and general laboratory instrumentation.
• Ability to work effectively in a fast-paced, cross-functional matrix environment.
• Familiarity with relevant FDA, EU, ICH guidelines, and regulations
• Bold, Relentless, Curious, and Collaborative.

Responsibilities

• Conduct Environmental Monitoring activities (routine, in-process monitoring, and EMPQs) across manufacturing areas to ensure compliance and control.
• Perform critical utility sampling, including Water for Injection (WFI) and compressed gas systems, maintaining the highest standards of sterility assurance.
• Maintain laboratory equipment, ensuring calibration, readiness, and adherence to housekeeping standards within GMP environments.
• Author, review, and execute SOPs, protocols, and technical reports with a high degree of accuracy and compliance.
• Perform data entry, review, and trending within LIMS, contributing to data integrity and enabling advanced analytics and digital insights.
• Coordinate sample management and testing with internal and external laboratories, ensuring timely and accurate results.
• Troubleshoot laboratory equipment and test methods, driving continuous operational efficiency.
• Support quality systems processes, including deviations, change controls, and CAPAs, ensuring thorough documentation and resolution.
• Participate in internal and external audits, contributing to inspection readiness and continuous improvement initiatives.
• Train and expand capabilities in microbiology lab techniques related to critical utilities testing, including bioburden and endotoxin assays.

Benefits

• Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Family planning benefits, including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investment opportunities to help you plan for the future
• Location-specific perks and extras

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 1,001-5,000 employees