- Responsible for supporting cGMP mRNA drug products produced internally at Moderna. They
will provide real-time quality oversight and expertise to enable technical success with stringent
adherence to a Quality System that respects global regulatory expectations. - Interact fluidly with peers and supervisors in Manufacturing, and cross-functionally with
Manufacturing, Quality Control, Logistical, and Process Development Technology Transfer
counterparts. -
Manage quality systems related to Moderna’s US-based distribution network including domestic
and international shipping lanes. - Closely partner with peers to support the disposition of Plasmid, Drug Substance, and Drug
Product. - Practice safe work habits and adhere to Moderna's safety procedures and guidelines.
- Utilize knowledge to improve operational efficiency. Evaluates department outputs for accuracy
and compliance with processing guidelines and departmental standards to validate process and
workflow effectiveness and efficiency. -
Oversee and review executed electronic and paper batch record documentation. Support quality
functional groups on a needed basis. -
Conducts research, compiles, and analyzes performance reports to identify the root cause of
problems and recommend process improvements. - Participates with stakeholders to develop potential preventive and/or corrective actions.
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