Quality Assurance, On-the-Floor at Moderna

Melbourne, Victoria, Australia -

Full Time

Start Date

Immediate

Expiry Date

09 Aug, 26

Salary

0.0

Posted On

11 May, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

cGMP Compliance, Quality Assurance, Sterile Drug Product Manufacturing, Drug Substance Manufacturing, Deviation Management, SOP Authoring, Batch Record Review, Risk Identification, Cross-functional Collaboration, Regulatory Compliance, Quality Systems, Operational Excellence

Industry

Biotechnology Research

Description

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 Moderna’s 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. Here’s what you’ll 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. Here’s What You’ll Need (Basic Qualifications) Bachelor’s degree in a science-related field (e.g. Biology, Microbiology, Chemistry, Pharmacy, Engineering) or equivalent experience. 3–5 years of pharmaceutical or related experience in a GMP environment. Here’s What You’ll 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 Moderna’s site full-time. This position is not eligible for remote work. As part of Moderna’s 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. That’s why our global benefits and well-being resources are designed to support you—at 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 Savings and investments 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, 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 leavesandaccommodations@modernatx.com. - Our Mission and Vision At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today. Third Party Staffing Agencies Moderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes. Reasonable Accommodation Notice Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing humanresources@modernatx.com if you need assistance completing any forms or to otherwise participate in the application process. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment. Return Home

Responsibilities

Provide real-time quality oversight and on-the-floor support for Drug Substance and sterile Drug Product manufacturing to ensure cGMP compliance. This includes monitoring process operations, managing deviations, and authoring quality documentation to maintain operational excellence.