Document Coordinator

Job title: Document Coordinator

Location: Swiftwater, PA

Join a global network that powers how Sanofi delivers - seamlessly, purposefully, and  Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.

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.

• 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

• 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

• 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

• 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

• 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 document management systems)
• Knowledge of test data review processes and data integrity principles
• Experience…