The Role Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience, with the potential to make a significant impact on patients' lives worldwide. Moderna is committed to enhancing Australia's biotech landscape through a long-term partnership that focuses on strengthening pandemic resilience. Our Melbourne-based large-scale mRNA vaccine manufacturing facility will be a cornerstone in Australia's ability to respond to future health threats efficiently. This collaboration not only brings cutting-edge medical technology to the forefront but also emphasizes job creation and local talent development. We're inviting visionary professionals to be part of this transformative journey, making a tangible impact on global health security. As a Quality Assurance Associate, you will be responsible for real-time, on-the-floor quality oversight of internal manufacturing at Moderna. This position ensures compliance with cGMP standards for the production of mRNA drug substances at our Melbourne facility. 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. This is a shift-based, individual contributor role requiring strong decision-making skills and an ability to escalate critical issues when necessary. Here’s What You’ll Do Your key responsibilities will be: 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. Your responsibilities will also include: Enforcing adherence to cGMPs, SOPs, and documentation for all manufacturing operations. Maintaining expertise in Quality Systems, including deviations, CAPAs, and change controls. Triaging and reviewing minor deviations while working with cross-functional teams. Reviewing executed batch records (both electronic and paper) to ensure regulatory compliance. Practicing safe work habits and ensuring adherence to safety protocols. Supporting a shift structure to ensure continuous oversight of manufacturing operations. Contributing to process improvements to enhance operational efficiency. The key Moderna Mindsets you’ll need to succeed in the role: We act with urgency – In this role, real-time quality oversight is critical. Your ability to swiftly assess situations, identify risks, and escalate concerns when necessary will directly impact the success of Moderna’s manufacturing operations. Every decision made today ensures the integrity of our products and the health of patients worldwide. We obsess over learning – The dynamic nature of mRNA manufacturing and GMP compliance requires continuous learning. You will be expected to stay ahead of evolving quality standards, adapt to new data, and improve processes based on real-time observations. By learning the fastest, you’ll contribute to a culture of continuous improvement in Moderna’s quality operations. Here’s What You’ll Need ( Basic Qualifications) Bachelor’s Degree in a science field (e.g., Biology, Microbiology, Chemistry, Pharmacy, Engineering) 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 is site-based, requiring you to be at Moderna’s site full-time. This position is not eligible for remote work. Here’s What You’ll Bring to the Table (Preferred Qualifications) A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative. 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. Quality healthcare and insurance benefits Lifestyle Spending Accounts to create your own pathway to well-being Free premium access to fitness, nutrition, and mindfulness classes Family planning and adoption benefits Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown Savings and investments 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 our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply Moderna is committed to equal opportunity in employment and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodation or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations and Adjustments team at leavesandaccommodationsmodernatx.com . -
