mRNA Associate, Internal Quality Assurance - Vaccine
Waltham, Massachusetts, Burlington, Massachusetts
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- Team player
Culture: Play to Win
Health & Wellness
Comprehensive coverage including medical, dental, vision, and health and wellness programs.
Sanofi wants to ensure employees are equipped for financial health, Sanofi provides a competitive 401K Match program and Financial Wel-Being Tools and Programs.
At Sanofi, we demonstrate our commitment to inclusion and diversity through Culture groups and programs. There are many ways to make a difference and connect with other Sanofi employees: including ERG groups and 2 PAID days off to Volunteer.
Sanofi provides significant Work/Life benefits to help you excel beyond the workday. Including Workplace Flexibility through part‑time, remote work, flex‑time and job share options.
"At Sanofi, We are guided by a deep appreciation and understanding of what it means to live with a rare blood disorder, and we learn by listening to the community – patients, caregivers physicians, and other healthcare professionals."
"Patients are at the center of all that we do at Sanofi. Our teams are focused on advancing transformational therapies that can address serious unmet needs for people living with rare blood disorders, and expanding global patient access to our medicines."
In the race for the future of health– The Sanofi mRNA Center of Excellence (CoE)
At Sanofi, we believe in a world in which no one suffers or dies from vaccine-preventable diseases. And while the pandemic has shaken up our industry, creating new opportunities and risks, we believe the acceleration of innovation with mRNA technology means vaccines for more people faster than before.
That’s why we’re looking for bold, optimistic world-changers to join the team at our mRNA Center of Excellence. We’re investing €400m a year into the new Center, hiring a team of 400 dedicated employees for it and using it as the foundation to implement integrated end-to-end mRNA vaccine capabilities and research with R&D, digital and CMC teams.
Bring your ambition and optimism for the future to Sanofi. Join us
About the opportunity
The Quality Assurance Sr. Associate I reports to the Manager, Internal Quality Assurance and is an integral part of the Quality team. This position offers opportunities to focus on disposition of product for Sanofi CoE, inclusive of review and release of manufacturing/test documentation from process development, manufacturing and nonclinical, clinical and commercial processes and supply chains. This includes batch records, deviations, CAPAs, CoAs, CoCs, etc.
Responsibilities for position
Reviews and approves master production records for the timely initiation of GMP manufacturing activities.
Person in Plant (PIP) for internal manufacturing operations.
Reviews executed batch records and related documentation, resolves compliance issues and dispositions lots of drug substance, bulk drug product, drug product and clinical materials for use in clinical trials
Perform lot release Quality Review of manufacturing and quality control records to ensure compliance with specifications and regulations.
Ensure that all requirements, as stipulated in the appropriate QTA, have been met.
Issue/Review documentation, i.e. Deviations, CAPAs, OOS etc., as they occur.
Write and revise SOP, forms, WI, and any other document types
Assist with internal and external audits.
Support of data analysis and metrics for QMR, KPIs, and other reportable forums may be requested.
Assume additional responsibilities as assigned.
Minimum 3 years of experience in Quality Assurance
Working knowledge and ability to apply Quality principles and cGMPs in conformance to standards, preferably gained from working in a manufacturing, QA or QC environment.
Demonstrated ability to interact and communicate effectively, both written and verbal, with peers, management, auditors, and consultants.
Must have excellent attention to detail, project and time management skills, and the ability to manage multiple priorities with aggressive timelines.
Preferred experience with outsourced manufacturing and testing operations
Working knowledge of MS Office products including Word, Excel, Outlook, PowerPoint, and Project.
Bachelor’s OR 5+ years of relevant experience
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.