mRNA – Quality Assurance Specialist – Vaccines
Principia Biopharma, Inc.
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
Intro about the position
About the Opportunity
The Quality Assurance Specialist reports to the Manager, External Quality Assurance and is an integral part of the Quality team. This position offers opportunities to focus on batch record review, lot disposition, deviations, investigations, CAPA, change controls and audits. In addition, this person is responsible for sample management include maintaining sample logs, managing sample coordination activities with manufacturing and contract testing laboratories.
Key responsibilities for position
About growing with us for winning with us
In this role you will….
Reviews and approves master production records for the timely initiation of GMP manufacturing activities.
Person in Plant for sample management activities.
Manages coordination for sample receipt from manufacturing and shipment to appropriate testing labs.
Manages the administrative aspects for handling the data received from testing laboratories and helps to create CoA, CoT, interim and final stability reports and related testing documentation.
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.
Competencies / Requirements for position
Qualifications/ Education & work experience
Bachelor’s and/or 8+ years of relevant experience
Minimum 5 years of experience in Quality
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.
Technical knowledge of cell therapy manufacturing operations/ process.
Experience with GMP regulations and Cell and Gene Therapy
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.
As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.
According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.
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.