Document Coordinator

Job title: Document Coordinator 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.  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 responsibilities: Test Data Review: • Ensuring that he/she is trained and qualified to the assigned analytical testing that requires to be qualified • Performing the QC data review of executed tests by other analysts in a timely manner, ensuring adherence to the committed scheduled plans • Informing his/her manager of any quality or HSE event (deviations, OOx,…) in a timely manner to ensure investigation and impact assessment are performed appropriately Participating actively to any investigation, where he/she is involved, to ensure investigations and impact assessment are performed appropriately • Support root cause analysis investigations for testing deviations Document coordination: • Coordinate quality control documentation lifecycle activities • Manage document workflows, including review, approval, and distribution processes • Ensure documentation compliance with good documentation practices (GDP) • Create, maintain, and update QC technical documentation and SOPs • Monitor document revision schedules and coordinate periodic reviews • Liaise with subject matter experts (SMEs) for document content development • Support metadata management and document control activities in quality systems (e.g., QualiPSO) • Coordinate stakeholder reviews and consolidate feedback Other accountabilities: • Executing assigned CAPAs related to remediation plans, continuous improvements • Ensuring that his/her lab/facilities, lab instruments are kept in a quality and safety status to ensure that they can be used appropriately. • Executing analytical testing in a timely manner, ensuring adherence to the committed scheduled plans • Performing his/her tasks in accordance with cGMP and HSE requirements, and with the associated instructions, procedures, records, related to these tasks • Recording all expected raw data, calculations, information, related to his/her tasks, to comply with cGMP and data integrity requirements • Supporting laboratory and deviation investigations Typical Activities: • Review test data for accuracy, completeness, and compliance • Coordinate the creation, review, and approval of QC SOPs and technical documents • Manage document change requests and assess impact on testing operations • Facilitate document review meetings with cross-functional teams • Maintain document control records and ensure proper version management • Support regulatory inspections by providing documentation and technical expertise • Participate in CAPA investigations related to testing or documentation issues • Monitor documentation metrics and report on completion status • Train laboratory personnel on new or revised procedures • About you Key Qualifications: • Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or related field • 3-5 years of experience in QC laboratory operations. Working in a pharmaceutical environment is preferred. • Strong understanding of GxP requirements and/or pharmaceutical quality systems • Experience with analytical testing methods and equipment • Proficiency in document management systems (e.g., QualiPSO, electronic docum