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Moderna

Senior Specialist, On-the-Floor, Quality Assurance

Moderna

full time · Senior

Listed on Moderna’s own careers site. You apply with them directly — we never stand between you and the employer.

What this role is

A quality assurance specialist providing real-time oversight of mRNA drug manufacturing and quality control operations at Moderna's Melbourne facility, ensuring compliance with cGMP standards and supporting continuous improvement. Ideal for someone with pharmaceutical manufacturing experience who enjoys hands-on quality work, cross-functional collaboration, and making direct patient impact in a high-growth biotech environment.

Our summary, not Moderna’s wording. The full posting is on their site.

Skills this role names

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What they ask for

Required

  • Bachelor's degree in science field (Biology, Microbiology, Chemistry, Pharmacy, Engineering) or equivalent
  • Minimum 5 years pharmaceutical, biopharmaceutical, or related work experience with cGMP emphasis
  • Working knowledge of Quality Systems and electronic systems (SAP, LIMS, MODA, eLN, CDS, batch records)
  • Site-based role in Melbourne, full-time on-location presence required

Nice to have

  • Strong working knowledge of cGMP regulations, ISO standards, data integrity expectations, and regulatory guidance
  • QA on-the-floor support experience in manufacturing operations and/or QC laboratories
  • Experience with regulatory inspections or audits as SME with health authority interaction
  • Experience with analytical or microbiological method validation, transfer, or qualification
  • Experience with OOS/OOT investigation management, deviations, and CAPAs
  • Understanding of QC microbiology, environmental monitoring, and contamination control
  • Ability to make risk-based quality decisions and escalate appropriately
  • Leadership, coaching, communication, and project management skills

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