QA Deviation Specialist - $55/hour/Norwood, MA/ 12 months+

  • 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
  • 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
  • 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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