Quality Assurance, On-the-Floor
Job Summary
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 Modernas 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.
Heres what youll 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.
Heres What Youll Need (Basic Qualifications)
Bachelors degree in a science-related field (e.g. Biology Microbiology Chemistry Pharmacy Engineering) or equivalent experience.
35 years of pharmaceutical or related experience in a GMP environment.
Heres What Youll 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 Modernas site full-time. This position is not eligible for remote work.
As part of Modernas 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. Thats why our global benefits and well-being resources are designed to support youat 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
Savingsandinvestments 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 theinfrastructure 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 peopleare the driving force behind our scientific progress and our 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 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 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 .
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About Company
Learn how we’re changing the world of medicine. Discover career opportunities, our product pipeline, and browse media resources. Meet Moderna.