Specialist, Quality Assurance On-the-floor

7 months ago

Melbourne, Australia Moderna Full time

**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.

Moderna is seeking a Quality Assurance Specialist for our Melbourne facility, focusing on drug product manufacturing. This role involves real-time, on-the-floor oversight, ensuring strict compliance with cGMP standards. As an integral member of our quality assurance team, you will collaborate with cross-functional teams to maintain the highest quality of mRNA drug products. Your expertise will be essential in making critical quality decisions and escalating operational issues, contributing significantly to Moderna's commitment to global health security through innovative mRNA technology.

Within 3 Months, You Will

Acclimate to Moderna's dynamic manufacturing environment, understanding the specific processes and quality systems.

Begin providing on-the-floor quality support, observing manufacturing activities and ensuring compliance with specifications.

Start conducting regular walkthroughs of manufacturing suites, ensuring proper maintenance and adherence to GMP practices.

Within 6 Months, You Will

Make crucial quality decisions and manage escalations that may impact manufacturing operations.

Collaborate with manufacturing and support teams on new deviation events and minor manufacturing deviations.

Contribute to authoring and reviewing essential documentation, aligning with regulatory and cGMP requirements.

Within 12 Months, You Will

Play a pivotal role in enforcing cGMP compliance and operational excellence in the manufacturing process.

Exhibit proficiency in reviewing and ensuring the accuracy of batch record documentation.

Be recognized for improving operational efficiency and maintaining the highest standards of safety and quality in our manufacturing processes.

**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

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.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet

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