QA Batch Review Specialist - Vaccines

Job Title: QA Batch Review Specialist - Vaccines

Location: Swiftwater, PA

About the Job:

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.

Main Accountabilities:

• 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.

Key Involvement in Decision Making:

• 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)

About You

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