Quality Assurance Operations Specialist - Vaccines
沃尔瑟姆, 麻薩諸塞州 Permanent 发布日期 11/06/2024At 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.
mRNAOperational QualityAssuranceSpecialist- Vaccines mRNA Center of Excellence
JobDescription:
Intheraceforthefutureofhealth-TheSanofimRNACenterofExcellence(CoE)
AtSanofi,webelieve inaworldinwhich no onesuffersor dies fromvaccine-preventablediseases. andwhilethepandemichasshakenupourindustry,creatingnewopportunities andrisks,webelieve theacceleration of innovation withmRNAtechnology means vaccines for morepeople faster than before.That'swhywe'relookingforbold,optimisticworld-changerstojointheteamatourmRNACenter ofExcellence. We'reinvesting €400mayearintothenewCenter,hiringateamof 400dedicated employeesforit andusingitasthefoundationtoimplementintegratedend-to-endmRNAvaccine capabilitiesandresearch.Bringyourambitionandoptimismfor thefuturetoSanofi.
Introabout 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 companywide 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 tomanage 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.
#GD-SP
#LI-SP
在美国的职位
加入我们的美国团队。我们将为您提供专家指导和培训平台，从而帮助我们营造良好的企业文化。我们鼓励您以饱满的热情和充沛的精力投入到工作中，然后发挥自身能力推进药物和疫苗的研发，同时将研发到临床治疗的时间减半。
体验可能性
-
Ama
Ama puts her project management techniques and ServiceNow knowledge to use to help advance Sanofi’s Digital Data operating model. Learn how our team connects data and AI to do what’s never been done before.
-
Cambridge Crossing
We're bringing together 2,500 people from across our organization — R&D, Medical, Commercial and Global colleagues all working to realize the power of collaboration.
-
Innovation in Action
Our flexible lab of the future will transform how we conduct research, while our innovation center will be fully integrated with existing R&D locations.
-
Sanofi’s AI Centre of Excellence in Toronto
The Centre is focused on using leading technologies to develop world-class data and artificial intelligence (AI) products to create value for the health sector.
-
Sanofi Canada's Philanthropic Efforts
By chasing the miracles of science to improve people’s lives, we surprise ourselves with what we can achieve. Our team is humbled by the impact our efforts make.
-
Sustainable and Green
Our new facility was built to minimize the environmental impact — helping protect our planet and people. Using resources efficiently, we're providing greener, healthier workspaces.
-
-
我们的办公地点
我们的员工遍布60多个国家/地区。他们勠力同心，携手共创医疗健康领域的美好未来。无论您在哪里工作，我们的专家都会指导您推动职业发展，您也将能够运用先进的科学技术，取得意义非凡的重大突破。
-
勇敢追梦，奔赴美好未来
想要改变自己的生活，乃至改变全球数百万人的生活，该怎么做？加入我们，开启职业新篇章，然后在我们的保驾护航中展翅高飞，并向优秀的人求教，为这份事业做出切实的贡献。
-
您和我们相互依存，共同成长
我们精心打造薪酬体系，为您的身心健康、财务健康与社交健康提供全面保障。我们有着海纳百川的包容性团队文化，无论您在哪个岗位，都能展翅高飞。
-
心怀梦想，成就一番事业
我们希望您以饱满的热情投入到自己的工作岗位中，给全球数百万人带来美好生活。您的职业发展道路由您自己来掌控。您只管制定目标，我们会提供充足的培训机会和支持，让您得偿所愿。
-
我们的人与文化
我们是首个建立多元化、公平性和包容性（DE&I）委员会的制药企业。我们还建立了“菲常联盟”，为每位员工提供发声的平台。您的声音是我们建设未来道路的重要基石。
-
我们的故事
我们关注每一个员工的声音。因为，我们的未来取决于所有员工的付出与努力。正因为他们的助力，我们才能追求远大的理想。
-
为什么选择我们？
我们为您提供各种工具、支持和培训机会，帮助您实现自己的目标。我们也希望您充分发挥潜力，帮助我们实现目标：将新药研发到临床治疗的时间减半。
