<p>Job Title: QA Batch Review Specialist - Vaccines</p> <p>Location: Swiftwater, PA</p> <p>About the Job:</p> <p>Join a global network that powers how Sanofi delivers - seamlessly, purposefully, and at scale. In Manufacturing & Supply, you'll help reimagine how life-changing treatments reach people everywhere, faster.</p> <p>We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Your job, as QA Batch review specialist within our Quality Assurance team, will be to ensure product quality through batch release processes to market for the Swiftwater Site.</p> <p>What makes this position unique?</p> <p>This role provides quality oversight of the batch release process. This role will perform final batch release and lot disposition for product distributed from the Sanofi Swiftwater Site and release from relevant Commercial Manufacturing Organizations (CMOs)</p> <p>Benefits of working in this role:</p> <ul> <li> <p>Be part of an inspiring mission to create life-saving vaccines</p> </li><li> <p>Leading a skilled and motivated team of quality professionals</p> </li><li> <p>The work environment is a highly collaborative and technical vaccine manufacturing operation on a beautiful park like campus.</p> </li></ul> <p>We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?</p> <p>About Sanofi:</p> <p>We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.</p> <p>Main Accountabilities:</p> <ul> <li> <p>Ensuring that activities in his/her scope are conducted in compliance with applicable regulatory requirements</p> </li><li> <p>Ensuring all batch release activities comply with Good Manufacturing Practices (GMP)</p> </li><li> <p>Reviewing batch records and associated documentation</p> </li><li> <p>Fostering a culture of quality and continuous improvement across the organization</p> </li><li> <p>Participating in internal and external audits and regulatory inspections providing support and documentation</p> </li><li> <p>Conducting risk assessments and implementing mitigation strategies for batch release processes</p> </li><li> <p>Participating to coordination of actions across teams (Quality Control, production) to ensure lot release in a timely manner following flow controller priorities</p> </li><li> <p>Investigating and resolving any issues or deviations related to batch release (including temperature excursion evaluation per product if distribution channel faces an unusual event)</p> </li><li> <p>Collaborating with regulatory affairs to ensure compliance with local and international regulations</p> </li><li> <p>Implementing continuous improvement initiatives to enhance batch release efficiency and effectiveness</p> </li><li> <p>Participating in Quality Alert/Product Alert meetings and ensuring that investigation and actions taken during those meetings allow the decision for disposition of lots</p> </li><li> <p>Perform and lead Environmental Data Summary Review, Lot Release Protocol generation/approval, and CMO release as applicable.</p> </li></ul> <p>Key Involvement in Decision Making:</p> <ul> <li> <p>Prioritize quality and compliance objectives (D)</p> </li><li> <p>Approve a batch record if it is correctly completed and meets the quality requirement for one lot (D)</p> </li><li> <p>Check whether all practices are done according to quality requirement; if not, assure that a deviation is opened and reported in the batch record (D)</p> </li><li> <p>Review and approve documentation for batch disposition (A)</p> </li><li> <p>Release of all stages of batches, focusing on the formulation, master/fill/inspect, and packaged stages</p> </li><li> <p>Advise on initiatives to promote a quality-focused culture (A)</p> </li><li> <p>Advise on how to present a topic and answer specific questions (A)</p> </li></ul> <p>About You</p> <p>Requirements:</p> <ul> <li> <p>Bachelor's degree required, preferably in Life Sciences, Engineering, or a related field</p> </li><li> <p>Minimum of 2 years experience in quality assurance within the pharmaceutical industry</p> </li><li> <p>Strong knowledge of Good Manufacturing Practices (GMP) and quality assurance principles</p> </li><li> <p>Role is an on-site position primarily Monday-Friday 1st shift, with potential flexibility as needed to meet release needs</p> </li></ul> <p>Skills/Knowledge:</p> <ul> <li> <p>Ability to meticulously review batch records and documentation to ensure accuracy and compliance with regulatory standards</p> </li><li> <p>Ability to analyze complex data and identify trends, issues, and solutions</p> </li><li> <p>Capability to investigate and resolve issues or deviations related to batch release processes efficiently</p> </li><li> <p>High level of accuracy and attention to detail in all quality assurance activities</p> </li><li> <p>Proficiency in identifying problems and implementing effective corrective actions</p> </li><li> <p>Ability to manage multiple projects simultaneously, ensuring timely completion and adherence to quality standards</p> </li><li> <p>Exhibit and Champion for Sanofi Take the Lead Behaviors</p> </li><li> <p>Strong verbal and written communication skills for effective interaction with team members and regulatory bodies</p> </li><li> <p>Fluent English spoken and written compulsory local language fluency may be compulsory</p> </li><li> <p>Good knowledge of Swiftwater Plant operations (preferred)</p> </li><li> <p>High level of autonomy</p> </li><li> <p>Strong Computer Literacy (including Microsoft excel, power point, word)</p> </li></ul> <p>Why Choose Us?</p> <ul> <li>Bring the miracles of science to life alongside a supportive, future-focused team. </li><li>Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. </li><li>Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. </li><li>Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. </li></ul> <p>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.</p> <p>#GD-SP</p> <p>#LI-SP</p> <p>#LI-Onsite</p> <p>#vhd</p> <p>Pursue progress, discover extraordinary</p> <p>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.</p> <p>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.</p> <p>Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!</p> <p>US and Puerto Rico Residents Only</p> <p>Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.</p> <p>North America Applicants Only</p> <p>The salary range for this position is:</p> <p>$78,000.00 - $112,666.66</p> <p>All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.</p>