Document Coordinator

Job title:

Document Coordinator

Location:

Swiftwater, PAAbout the jobJoin 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. 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 SOPsMonitor 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 youKey

Qualifications:

Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or related field3-5 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…