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Quality Assurance Operations Specialist - Vaccines

Synthorx

Synthorx

Operations, Quality Assurance
Waltham, MA, USA
Posted on Tuesday, May 21, 2024

At Sanofi, we chase the miracles of science to improve people’s lives. We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people.

mRNA Operational Quality Assurance Specialist- Vaccines mRNA Center of Excellence

Job Description:

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. Bring your ambition and optimism for the future to Sanofi.

Intro about the position

Objectives of this role

  • Interpret, build upon and comply with company quality assurance standards

  • Maintain significant and non-significant event processing through records and tracking systems, including root-cause analysis and corrective actions

  • Document quality assurance activities with internal reporting and audits

  • Identify training needs and take action to ensure company wide compliance

  • Shop floor quality support for Manufacturing

In this role you will ....

  • Assist operations by tracking, documenting and supporting the development and approval of Deviations, CAPAs, Change Controls, Lab Investigations and SOPs.

  • Investigate reports of product quality issues and ensure resolution in accordance with company guidelines and regulatory requirements.

  • Reviews QC analytical data from in-process, release and stability testing.

  • Support the Risk Management program by leading proactive risk management activities for the mRNA Center of Excellence.

  • Provide training and support to quality assurance team members that covers systems, policies, procedures, and core processes.

  • Supports and/ or leads product quality investigations (manufacturing process, analytical, and operations), ensuring they are adequate and cGMP compliant.

  • Identifies and recommends appropriate CAPA as needed for investigations and evaluates CAPA effectiveness check.

  • Supports collaborative efforts for and with audit and inspection teams.

  • Tracks and trends metrics that are product or process related as directed by the management.

  • Ensures risks are identified, communicated and critical issues are escalated, followed up through until addressed, and proactively assists with risk mitigation plans.

  • Works independently and meets timelines, objectives, and deliverables in principle.

  • Assume additional responsibilities as assigned.

  • Person in Plan for Quality oversight of Manufacturing operations.

Qualifications/ Education & work experience

  • Bachelor's and/or 8+ years of relevant experience

  • Minimum 6 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 manufacturing operations/ process.

  • Experience with GMP regulations and preferably mRNA processes

  • 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.

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.

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Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!