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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 including real-time observation of activities. Monitor process operations to ensure compliance with specifications. Make quality decisions and/or escalates issues to management that may impact operations. Identify risks and communicate gaps for quality and GMP process/systems Perform routine walkthroughs of the manufacturing suites to ensure appropriate suite maintenance, implementation of GMP best practices, and troubleshooting when problems arise. Enforce adherence to cGMPs, SOPs, and manufacturing documentation. Partner with manufacturing and support teams to initiate and triage new deviation events, reviews minor manufacturing deviations. Author and review documentation, including SOPs and WIs, to ensure compliance and adherence to regulations/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 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 Le R\u00f4le : Moderna recherche un Sp\u00e9cialiste en Assurance Qualit\u00e9 pour assurer la surveillance en temps r\u00e9el de la qualit\u00e9 de la fabrication interne chez Moderna Inc. Le titulaire du poste int\u00e9grera une \u00e9quipe d\u00e9di\u00e9e au soutien de la substance m\u00e9dicamenteuse d'ARNm conforme aux cGMP produite en interne chez Moderna, et collaborera avec les Op\u00e9rations, la Science et la Technologie de Fabrication, ainsi que d'autres fonctions. Il apportera une expertise et une surveillance de la qualit\u00e9 en temps r\u00e9el pour garantir un succ\u00e8s technique tout en respectant rigoureusement le Syst\u00e8me de Qualit\u00e9. Une capacit\u00e9 \u00e0 prendre des d\u00e9cisions de mani\u00e8re autonome sera essentielle \u00e0 la r\u00e9ussite du candidat. Il sera attendu du titulaire du poste qu'il prenne des d\u00e9cisions et/ou escalade les probl\u00e8mes \u00e0 la direction survenant lors des op\u00e9rations. Voici Ce Que Vous Ferez : Assurer un soutien Qualit\u00e9 sur le terrain \u00e0 la Fabrication, y compris l'observation en temps r\u00e9el des activit\u00e9s. Veiller \u00e0 la conformit\u00e9 des op\u00e9rations de processus aux sp\u00e9cifications. Prendre des d\u00e9cisions de qualit\u00e9 et/ou escalader les probl\u00e8mes \u00e0 la direction susceptibles d'affecter les op\u00e9rations. Identifier les risques et communiquer les lacunes en mati\u00e8re de qualit\u00e9 et des processus/syst\u00e8mes GMP. R\u00e9aliser des visites r\u00e9guli\u00e8res des suites de fabrication pour garantir un entretien appropri\u00e9, la mise en \u0153uvre des meilleures pratiques GMP, et intervenir en cas de probl\u00e8mes. Veiller au respect des cGMP, des SOP, et de la documentation de fabrication. Collaborer avec les \u00e9quipes de fabrication et de soutien pour initier et trier les nouveaux \u00e9v\u00e9nements de d\u00e9viation, et examiner les d\u00e9viations mineures de fabrication. R\u00e9diger et r\u00e9viser la documentation, y compris les SOP et les WI, pour assurer la conformit\u00e9 et le respect des op\u00e9rations/r\u00e9glementations cGMP. Examiner la documentation ex\u00e9cut\u00e9e des dossiers de lot \u00e9lectroniques et papier. Respecter les habitudes de travail s\u00fbres et adh\u00e9rer aux proc\u00e9dures et directives de s\u00e9curit\u00e9 de Moderna. Utiliser les connaissances pour am\u00e9liorer l'efficacit\u00e9 op\u00e9rationnelle. Travailler selon une structure de quarts de travail. Voici Ce Que Vous Apporterez \u00e0 la Table : Dipl\u00f4me de baccalaur\u00e9at dans un domaine scientifique (par exemple, Biologie, Microbiologie, Chimie, Pharmacie, Ing\u00e9nierie) ou combinaison \u00e9quivalente d'\u00e9ducation et d'exp\u00e9rience 3 \u00e0 5 ans d'exp\u00e9rience de travail en pharmacie ou dans un domaine connexe, avec un accent sur les Bonnes Pratiques de Fabrication actuelles 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. 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 proud to be an equal opportunity workplace and is an affirmative action employer. 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. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. 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. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. 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