Senior Specialist Quality Assurance On-the-floor

The Role

Joining Moderna offers the unique opportunity to be part of a pioneering team thats revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases.

As an employee youll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide contributing to global health initiatives.

Modernas 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 Australias biotech landscape through a longterm partnership that focuses on strengthening pandemic resilience. Our Melbournebased largescale mRNA vaccine manufacturing facility will be a cornerstone in Australias ability to respond to future health threats efficiently. This collaboration not only brings cuttingedge medical technology to the forefront but also emphasizes job creation and local talent development. Were 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 realtime onthefloor 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 Modernas Quality System.

This is a shiftbased individual contributor role requiring strong decisionmaking skills and an ability to escalate critical issues when necessary.

Heres What Youll Do

Your key responsibilities will be:

• Providing onthefloor Quality support to Manufacturing including realtime 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 crossfunctional 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 youll need to succeed in the role:

• We act with urgency In this role realtime quality oversight is critical. Your ability to swiftly assess situations identify risks and escalate concerns when necessary will directly impact the success of Modernas 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 realtime observations. By learning the fastest youll contribute to a culture of continuous improvement in Modernas quality operations.

Heres What Youll Need Basic Qualifications)

• Bachelors 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 .

• This position is sitebased requiring you to be at Modernas site fulltime. This position is not eligible for remote work.

Heres What Youll Bring to the Table (Preferred Qualifications)

• A desire to make an impact as part of a highgrowth 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. Thats why our global benefits and wellbeing resources are designed to support youat work at home and everywhere in between.

• Quality healthcare and insurance benefits
• Lifestyle Spending Accounts to create your own pathway to wellbeing
• 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 yearend shutdown
• Savingsandinvestments
• Locationspecific 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 theinfrastructure to reimagine how medicines are created and delivered and a worldclass 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 peopleare 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 inperson culture is critical to our success. Moderna champions the significant benefits of inoffice collaboration by embracing a 70/30 work model. This 70 inoffice 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/careers to learn more about our current opportunities.

Moderna is a smokefree alcoholfree and drugfree 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 nondiscrimination for all employees and qualified applicants without regard to a persons 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.

Were 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 .