Quality Assurance, On-the-Floor

The Role: Reporting to the QA Operations Head, MTC-M, the Quality Assurance On-the-Floor Specialist is accountable for providing real-time quality oversight of manufacturing operations at Moderna’s Melbourne site. This role ensures adherence to cGMP requirements and supports both Drug Substance and sterile Drug Product manufacturing through proactive quality engagement. This role provides end-to-end oversight of on-the-floor quality activities, ensuring compliance with quality systems, regulatory expectations, and operational excellence. The role supports cross-functional teams including Operations, Manufacturing Science and Technology (MSAT), and Engineering to enable successful and compliant manufacturing outcomes. This position contributes to maintaining a strong quality culture, driving continuous improvement, and ensuring readiness for inspection and validation activities. Here’s 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. Here’s What You’ll Need (Basic Qualifications) 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. Here’s What You’ll Bring to the Table (Preferred Qualifications) 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. As part of Moderna’s commitment to workplace health and safety, this role may be subject to pre-employment and periodic medical assessments, in line with relevant legal and operational requirements. Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work.  That’s why our global benefits and well-being resources are designed to support you—at work, at home, and everywhere in between. Best-in-class healthcare, plus voluntary benefit programs to support your unique needs A holistic approach to well-being with access to fitness, mindfulness, and mental health support Family building benefits, including fertility, adoption, and surrogacy support Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown Savings and investments to help you plan for the future Location-specific perks and extras The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work. About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving ou ... (truncated, view full listing at source)