Specialist, Quality Assurance - On the Floor
Location
Laval, QC | Canada
Job description
- We are excited to announce that we are expanding our team and have multiple positions available for this role - join us in shaping the future!*
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.
In Laval, Moderna's long-term strategic partnership with the Canadian Government is revolutionizing the nation's pandemic preparedness and response capabilities. Our upcoming state-of-the-art mRNA vaccine manufacturing facility will play a pivotal role in ensuring rapid access to vaccines for respiratory viruses. We're investing in local talent development and research collaborations, strengthening Canada's position as a global center of mRNA excellence.
Moderna is seeking a Quality Assurance Specialist for real-time, on-the-floor quality oversight of internal manufacturing operations in Canada. This role is critical in supporting cGMP mRNA drug substance production and involves close collaboration with Operations, Manufacturing Science and Technology, and other functions. The successful candidate will provide quality oversight, make critical decisions, and escalate issues as necessary during operations.
Here’s What You’ll Do: Within 3 Months, You Will…
Provide on-the-floor Quality support to Manufacturing, including real-time observation of activities and monitoring process operations for compliance with specifications.
Start making quality decisions and escalate issues to management that may impact operations, while identifying risks and communicating gaps in quality and GMP processes/systems.
Within 6 Months, You Will…
Perform routine walkthroughs of the manufacturing suites, ensuring appropriate suite maintenance, implementation of GMP best practices, and troubleshooting issues.
Enforce adherence to cGMPs , SOPs, and manufacturing documentation, and partner with manufacturing and support teams for new deviation events and minor manufacturing deviation reviews.
Within 12 Months, You Will: Author and review documentation, including SOPs and WIs, to ensure compliance and adherence to regulations/cGMP operations.
Practice safe work habits and adhere to Moderna’s safety procedures and guidelines, utilizing knowledge to improve operational efficiency.
Operate effectively within a shift structure, making independent decisions and escalating issues when necessary.
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 .
Fluency in French and English as working language.
- Nous sommes ravis d'annoncer que nous agrandissons notre équipe et avons plusieurs postes disponibles pour ce rôle - bâtissons l'avenir ensemble!*
Le rôle: Rejoindre Moderna, c'est participer à une équipe pionnière qui révolutionne la médecine avec la technologie de l'ARNm et un large éventail de programmes de développement couvrant diverses maladies. En tant qu'employé, vous ferez partie d'une organisation en croissance continue, travaillant aux côtés de collègues exceptionnels et de partenaires stratégiques dans le monde entier, contribuant aux initiatives de santé mondiale. L'engagement de Moderna à faire avancer la frontière technologique des médicaments à ARNm garantit une expérience de carrière stimulante et gratifiante, avec un impact significatif sur la vie des patients partout dans le monde.
À Laval, le partenariat stratégique à long terme de Moderna avec le gouvernement canadien transforme les capacités du pays en matière de préparation et de réponse aux pandémies. Notre future installation de fabrication de vaccins à ARNm de pointe jouera un rôle crucial pour assurer un accès rapide aux vaccins contre les virus respiratoires, sous réserve de l'approbation de Santé Canada. Nous investissons dans le développement des talents locaux et favorisons les collaborations en recherche et développement, renforçant ainsi la position du Canada en tant que centre mondial d'excellence en ARNm.
Moderna recherche un Spécialiste de l'Assurance Qualité pour une supervision qualité en temps réel sur le terrain des opérations de fabrication internes au Canada. Ce rôle est essentiel pour soutenir la production de substances médicamenteuses d'ARNm conformément aux BPF chez Moderna et implique une collaboration étroite avec les Opérations, la Science et la Technologie de Fabrication et d'autres fonctions. Le candidat retenu fournira une supervision qualité et prendra des décisions critiques, tout en escaladant les problèmes au besoin pendant les opérations.
Voici Ce Que Vous Ferez : Dans les 3 Mois, Vous Allez…
Fournir un soutien qualité sur le terrain à la Fabrication, y compris l'observation en temps réel des activités et le suivi des opérations de processus pour assurer la conformité aux spécifications.
Prendre des décisions de qualité et/ou escalader les problèmes à la direction pouvant impacter les opérations, tout en identifiant les risques et les lacunes pour la qualité et les processus/systèmes BPF.
Dans les 6 Mois, Vous Allez…
Effectuer des visites régulières des suites de fabrication pour assurer une maintenance appropriée des suites, l'implémentation des meilleures pratiques BPF et la résolution de problèmes.
Faire respecter l'adhésion aux BPF, aux SOP et à la documentation de fabrication, et collaborer avec les équipes de fabrication et de support pour initier et trier les nouveaux événements de déviation.
Dans les 12 Mois, Vous Allez: Rédiger et revoir la documentation, y compris les SOP et les WIs , pour assurer la conformité et l'adhésion aux réglementations et opérations BPF.
Pratiquer des habitudes de travail sûres et adhérer aux procédures et directives de sécurité de Moderna, en utilisant les connaissances pour améliorer l'efficacité opérationnelle.
Opérer efficacement dans une structure de quarts de travail, prenant des décisions indépendantes et escaladant les problèmes lorsque nécessaire.
Voici Ce Que Vous Apporterez à la Table : Diplôme de baccalauréat dans un domaine scientifique (par exemple, Biologie, Microbiologie, Chimie, Pharmacie, Ingénierie) ou combinaison équivalente d'éducation et d'expérience
3 à 5 ans d'expérience de travail en pharmacie ou dans un domaine connexe, avec un accent sur les Bonnes Pratiques de Fabrication actuelles .
Maîtrise du français et de l'anglais en tant que langues de travail.
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 [email protected] . (EEO/AAP Employer)
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