Specialist, Quality Assurance – On‑the‑Floor

About the role

The Quality Assurance On‑the‑Floor Specialist provides real‑time quality oversight of manufacturing operations at Moderna’s Melbourne site, ensuring compliance with cGMP requirements for both drug substance and sterile drug product manufacturing.

Key responsibilities

• Observe manufacturing activities on the floor, monitor processes against specifications and regulatory requirements.
• Make quality decisions, escalate issues, and identify risks that could affect product quality.
• Conduct routine walkthroughs of suites, enforce cGMP, SOPs and documentation compliance.
• Partner with operations, MSAT and engineering to triage deviations and review minor deviation events.
• Author and review SOPs, work instructions and batch records.

Required profile

• Bachelor’s degree in a science‑related field or equivalent experience.
• 3–5 years of experience in a GMP environment, preferably in sterile drug product manufacturing.
• Strong understanding of cGMP requirements and quality systems.
• Ability to make independent decisions and communicate gaps in quality systems.

Required skills

• cGMP compliance
• SOP development and review
• Batch record documentation
• Sterile drug product manufacturing processes