Associate II, Quality Control, Stability

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* The Role:

** Moderna is seeking a Quality Control Stability Associate II to join our QC Stability team in Norwood, MA. This role will support the routine execution of GMP stability programs across clinical and commercial programs, ensuring activities are performed in accordance with established procedures, policies, and applicable GxP and GMP requirements.  The individual will play an important role in maintaining the consistent, compliant, and efficient execution of QC Stability operations.
** Here’s What You’ll Do
*** Performing day-to-day routine stability program operations, such as stability sample pulls, sample aliquoting, sample submissions to testing labs, set-downs, sample verifications, additional sample requests, and shipment preparations for external labs.
* Creating, maintaining, and assisting with stability scheduling ensuring stability sample pulls occur as scheduled and within defined timelines.
* Ensuring proper operation and functioning of stability controlled-temperature units and cold rooms within validated temperature ranges and loading patterns.
* Responding to notifications of out-of-range controlled-temperature units and cold rooms within scheduled working hours and escalating to QC Stability management.
* Ensuring proper handling of stability study materials and stability samples with attention to all material handling requirements in applicable procedures and protocols.
* Managing and stocking of QC lab supplies and consumables required for performing stability operations.
* Ensuring compliance with all lab safety requirements.
* Following all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
* Executing tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.
* Following Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
* Completing training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.
* May support and/or participate in audits and regulatory inspections.
** Here’s What You’ll Need (Basic Qualifications)**
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* Education:

** Bachelor’s degree in relevant scientific discipline
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* Experience:

** 2-3 years in a GMP QC laboratory setting with focus on Stability (preferable in life science or equivalent)
* Minimum knowledge required: cGMPs, general laboratory safety
* Minimum skills required:  + Pipetting  + Proficiency with Microsoft Office Programs  + Familiarity with electronic databases (e.g. LIMS, SAP, eQMS, CMMS)
* Strong written and oral communication skills as well as organizational skills
** Our Working Model
** As we build our company, we have always believed that an in-person culture is critical to our success. This role is 100% onsite, reflecting the importance of being physically present to support the work, collaborate closely with colleagues, and contribute to our site-based operations.

Working onsite enables real-time collaboration, strong team connections, direct mentorship, and the hands-on partnership needed to deliver our mission. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.

Moderna is a smoke-free, alcohol-free, and drug-free work environment.  
** Pay & Benefits
**** At Moderna, we believe that when you feel your best, you can do your best work.*
* ** That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.
*** Competitive healthcare, plus…