Specialist, Quality Assurance

3 weeks ago

Laval, Canada Moderna Full time

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.

**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.

**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 S

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