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Real-time Quality Manager

1 week ago

Melbourne, Victoria, Australia Moderna Therapeutics Full time

Job Summary:

We are seeking a highly skilled Senior Manufacturing Quality Associate to join our team at Moderna Therapeutics.

In this role, you will be responsible for providing real-time quality oversight of internal manufacturing operations, ensuring compliance with current Good Manufacturing Practices (cGMP) standards.

You will collaborate closely with Operations, Manufacturing Science and Technology, and other teams to ensure operational excellence while maintaining strict adherence to Moderna's Quality System.

Key Responsibilities:

  • Providing on-the-floor Quality support to Manufacturing, including real-time observation of activities to ensure compliance.
  • Monitoring process operations to ensure adherence to specifications.
  • Scheduling and allocating work resources for effective quality oversight.
  • Making critical quality decisions and escalating issues to management when needed.
  • Performing routine walkthroughs of manufacturing suites to ensure GMP compliance and best practices.

Requirements:

  • Bachelor's Degree in a science field or equivalent combination of education and experience.
  • Minimum 5 years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices.
  • Knowledge and use of electronic systems, including SAP, LIMS, and MODA, for batch release, deviations, lab data management, and manufacturing execution.
  • This position requires full-time site presence, with no remote work options.