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 document management systems)
Knowledge of test data review processes and data integrity principles
Experience coordinating documentation workflows and managing stakeholder reviews
Excellent attention to detail and organizational skills
Strong written and verbal communication skills
Knowledge of iShift…