Specialist, Quality Assurance

**The Role**:
**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 Rôle**:
**Voici Ce Que Vous Ferez**:
Assurer un soutien Qualité sur le terrain à la Fabrication, y compris l'observation en temps réel des activités. Veiller à la conformité des opérations de processus aux spécifications.

Prendre des décisions de qualité et/ou escalader les problèmes à la direction susceptibles d'affecter les opérations. Identifier les risques et communiquer les lacunes en matière de qualité et des processus/systèmes GMP.

Réaliser des visites régulières des suites de fabrication pour garantir un entretien approprié, la mise en œuvre des meilleures pratiques GMP, et intervenir en cas de problèmes.

Veiller au respect des cGMP, des SOP, et de la documentation de fabrication.

Collaborer avec les équipes de fabrication et de soutien pour initier et trier les nouveaux événements de déviation, et examiner les déviations mineures de fabrication.

Rédiger et réviser la documentation, y compris les SOP et les WI, pour assurer la conformité et le respect des opérations/réglementations cGMP. Examiner la documentation exécutée des dossiers de lot électroniques et papier.

Respecter les habitudes de travail sûres et adhérer aux procédures et directives de sécurité de Moderna.

Utiliser les connaissances pour améliorer l'efficacité opérationnelle.

Travailler selon une structure de quarts de travail.

**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

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.

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, pleas