Specialist, Quality Assurance, On-The-Floor
vor 2 Monaten
Specialist, Quality Assurance, On-the-FloorJoining 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.Moderna is seeking a Quality Assurance Specialist responsible for real-time on-the-floor quality oversight of internal manufacturing at Moderna Inc. The individual in this role will be part of a cohesive team responsible for supporting cGMP mRNA drug substance produced internally at Moderna and will work cross-functionally with Operations, Manufacturing Science and Technology, and other functions. They will provide real-time quality oversight and expertise to enable technical success with stringent adherence to the Quality System. Strong decision-making skills and independent thinking will be paramount for candidate success. They will be expected to make decisions and/or escalate issues to management that occur during operations.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, 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 experience preferred.This position is site-based, requiring you to be at Moderna's site full-time. This position is not eligible for remote work.About ModernaSince 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.Moderna is committed to equal employment opportunity 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.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
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