Quality Assurance On-the-Floor Specialist

About the Role The Quality Assurance On-the-Floor Specialist provides real-time quality oversight of Moderna’s Melbourne manufacturing operations, ensuring adherence to cGMP and supporting both Drug Substance and sterile Drug Product manufacturing. The role delivers end-to-end on-the-floor quality oversight, collaborating with Operations, MSAT, and Engineering to enable compliant manufacturing and readiness for inspection and validation activities. What You'll Do

• Provide on-the-floor Quality support to Manufacturing (Drug Substance and sterile Drug Product), including real-time observation of activities.
• Monitor process operations to ensure compliance with specifications and regulatory requirements.
• Make quality decisions and escalate issues that may impact operations or product quality.
• Identify risks and communicate gaps in quality systems and GMP processes.
• Perform routine walkthroughs of manufacturing suites to ensure GMP compliance and troubleshoot issues.
• Enforce adherence to cGMPs, SOPs, and manufacturing documentation.
• Partner with manufacturing and support teams to initiate and triage deviation events and review minor deviations.
• Author and review documentation, including SOPs, work instructions, and batch records.
• Ensure safe work practices in line with Moderna procedures and guidelines.
• Support continuous improvement initiatives to enhance operational efficiency.
• Complete required training and maintain qualifications in line with role expectations. What We're Looking For
• Bachelor’s degree in a science-related field (e.g. Biology, Microbiology, Chemistry, Pharmacy, Engineering) or equivalent experience.
• 3–5 years of pharmaceutical or related experience in a GMP environment.
• Experience in sterile drug product manufacturing (preferred).
• Strong understanding of cGMP requirements and quality systems.
• Ability to make independent decisions and escalate issues appropriately.
• Strong cross-functional collaboration and communication skills.
• Attention to detail with a focus on compliance and quality.
• This position is site-based, requiring you to be at Moderna’s site full-time. This position is not eligible for remote work. Nice to Have
• Experience in sterile drug product manufacturing (preferred).