Specialist, Quality Assurance, On-the-floor

**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 solidifying its presence in Clayton, Australia—a vibrant hub of pharmaceutical innovation. As we expand our manufacturing capabilities, we're inviting professionals who are passionate about quality assurance to join us in ensuring the highest standards of mRNA medicine production.
**Here’s What You’ll Do**:Your key responsibilities will be**:
Provide on-the-floor Quality support to Manufacturing (Drug Substance and sterile Drug Product), including real-time observation of activities, and monitor process operations to ensure compliance with specifications.
Make quality decisions and escalate issues to management that may impact operations. Identify risks and communicate gaps in quality and GMP process/systems.
Perform routine walkthroughs of manufacturing suites to ensure appropriate suite maintenance, implementation of GMP best practices, and troubleshooting when problems arise.
**Your responsibilities will also include**:
Enforce adherence to cGMPs, SOPs, and manufacturing documentation.
Partner with manufacturing and support teams to initiate and triage new deviation events, reviewing minor manufacturing deviations.
Author and review documentation, including SOPs and Work Instructions, to ensure compliance with regulations and cGMP operations. Review executed electronic and paper batch record documentation.
Practice safe work habits and adhere to Moderna’s safety procedures and guidelines.
Utilize knowledge to improve operational efficiency.
Operate on a shift structure.
**The key Moderna Mindsets you’ll need to succeed in the role**:
**We behave like owners**: You will be expected to take full ownership of the quality oversight process, making decisions that directly impact manufacturing operations.
**We prioritize the platform over any single solution**: Your focus will be on ensuring that the manufacturing process adheres to the highest quality standards, contributing to the overall success of Moderna's mRNA platform.
**Here’s What You’ll Bring to the Table**:
Bachelor’s Degree in a science field (e.g., Biology, Microbiology, Chemistry, Pharmacy, Engineering) or equivalent combination of education and experience
3 - 5 years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices
Sterile drug product manufacturing experienced preferred
This position is site-based, requiring you to be at Moderna’s site full-time. This position is not eligible for remote work.
Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.
We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
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, and a discretionary year-end shutdown
Educational resources
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 w