Associate II, Quality Control, Stability

ModernaTX • Norwood, MA

9d • Onsite

About The Position

Moderna is seeking a Quality Control Stability Associate II to join its QC Stability team in Norwood, Massachusetts. The role supports routine execution of GMP stability programs across clinical and commercial programs, ensuring work is performed according to established procedures, company policies, and applicable GxP and GMP requirements. The Associate II contributes to consistent, compliant, and efficient QC Stability operations.

The position is 100% onsite. Moderna describes its workplace as smoke-free, alcohol-free, and drug-free. Employment is contingent on the candidate qualifying as a U.S. person under applicable export control laws; Moderna is unable to sponsor non-U.S. persons to apply for an export control license.

Requirements

• Bachelor’s degree in a relevant scientific discipline.
• 2–3 years of experience in a GMP QC laboratory setting, with a focus on stability; life science experience or equivalent is preferred.
• Knowledge of cGMPs and general laboratory safety.
• Pipetting skills.
• Proficiency with Microsoft Office programs.
• Familiarity with electronic databases such as LIMS, SAP, eQMS, or CMMS.
• Strong written and oral communication skills.
• Strong organizational skills.
• Must qualify as a U.S. person under applicable U.S. export control laws; the company cannot sponsor non-U.S. persons for an export control license.

Responsibilities

• Perform routine stability program operations, including stability sample pulls, aliquoting, submissions to testing labs, set-downs, verifications, additional sample requests, and preparations for shipment to external labs.
• Create, maintain, and assist with stability schedules, ensuring sample pulls occur as scheduled and within defined timelines.
• Ensure stability controlled-temperature units and cold rooms operate properly within validated temperature ranges and loading patterns.
• Respond during scheduled working hours to notifications of out-of-range controlled-temperature units and cold rooms, and escalate issues to QC Stability management.
• Handle stability study materials and samples according to applicable procedures and protocols.
• Manage and stock QC lab supplies and consumables needed for stability operations.
• Comply with laboratory safety requirements, applicable GxP regulations and guidelines, and company policies.
• Execute tasks according to internal guiding documents, including standard operating procedures and work instructions.
• Follow Good Documentation Practices and Data Integrity requirements; complete and maintain records to support business use, audits, and inspections.
• Complete assigned learning-plan training on schedule and meet prescribed requalification cadence.
• Support and/or participate in audits and regulatory inspections as needed.

Benefits

• Competitive healthcare and voluntary benefit programs.
• Fitness, mindfulness, and mental health support.
• Family planning benefits, including fertility, adoption, and surrogacy support.
• Paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown.
• Savings and investment programs.
• Location-specific perks and extras.
• May be eligible for an annual discretionary bonus, other incentive compensation, or an equity award, subject to plan eligibility criteria and individual performance.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level