QA Batch Review Specialist - Vaccines

Sanofi • Swiftwater, PA

3d • $78,000 - $112,667 • Onsite

About The Position

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. 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. What makes this position unique? 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) Benefits of working in this role : Be part of an inspiring mission to create life-saving vaccines Leading a skilled and motivated team of quality professionals The work environment is a highly collaborative and technical vaccine manufacturing operation on a beautiful park like campus. 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? About Sanofi: 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.

Requirements

• Bachelor’s degree required, preferably in Life Sciences, Engineering, or a related field
• Minimum of 2 years experience in quality assurance within the pharmaceutical industry
• Strong knowledge of Good Manufacturing Practices (GMP) and quality assurance principles
• Ability to meticulously review batch records and documentation to ensure accuracy and compliance with regulatory standards
• Ability to analyze complex data and identify trends, issues, and solutions
• Capability to investigate and resolve issues or deviations related to batch release processes efficiently
• High level of accuracy and attention to detail in all quality assurance activities
• Proficiency in identifying problems and implementing effective corrective actions
• Ability to manage multiple projects simultaneously, ensuring timely completion and adherence to quality standards
• Exhibit and Champion for Sanofi Take the Lead Behaviors
• Strong verbal and written communication skills for effective interaction with team members and regulatory bodies
• Fluent English spoken and written compulsory local language fluency may be compulsory
• High level of autonomy
• Strong Computer Literacy (including Microsoft excel, power point, word)

Nice To Haves

• Good knowledge of Swiftwater Plant operations (preferred)

Responsibilities

• Ensuring that activities in his/her scope are conducted in compliance with applicable regulatory requirements
• Ensuring all batch release activities comply with Good Manufacturing Practices (GMP)
• Reviewing batch records and associated documentation
• Fostering a culture of quality and continuous improvement across the organization
• Participating in internal and external audits and regulatory inspections providing support and documentation
• Conducting risk assessments and implementing mitigation strategies for batch release processes
• Participating to coordination of actions across teams (Quality Control, production) to ensure lot release in a timely manner following flow controller priorities
• Investigating and resolving any issues or deviations related to batch release (including temperature excursion evaluation per product if distribution channel faces an unusual event)
• Collaborating with regulatory affairs to ensure compliance with local and international regulations
• Implementing continuous improvement initiatives to enhance batch release efficiency and effectiveness
• Participating in Quality Alert/Product Alert meetings and ensuring that investigation and actions taken during those meetings allow the decision for disposition of lots
• Perform and lead Environmental Data Summary Review, Lot Release Protocol generation/approval, and CMO release as applicable.
• Prioritize quality and compliance objectives (D)
• Approve a batch record if it is correctly completed and meets the quality requirement for one lot (D)
• 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)
• Review and approve documentation for batch disposition (A)
• Release of all stages of batches, focusing on the formulation, master/fill/inspect, and packaged stages
• Advise on initiatives to promote a quality-focused culture (A)
• Advise on how to present a topic and answer specific questions (A)

Benefits

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level