Oscar Hernandez
Third Party Management Documentation Specialist @Sanofi
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WORK HISTORY
Third Party Management Documentation Specialist @Sanofi
Manage controlled material records and specifications for quality-managed materials used in vaccine manufacturing, including raw materials, components, packaging, and contracted services.• Support approval and release of material specifications enabling MSAT (Manufacturing Science and Technology) to proceed with ordering and qualification activities.• Process supplier notifications and collaborate with subject matter experts to assess impact and ensure compliance with quality and regulatory standards.• Create, revise, and maintain material specifications to ensure accuracy, traceability, and alignment with global requirements.• Initiate and track change controls, supporting lifecycle management of materials and services.• Coordinate cross-functionally with Quality, Procurement, Technical Operations, and Regulatory Affairs to ensure timely execution of documentation workflows.• Utilize Veeva Vault and ERP systems (SAP/iShift) to manage documentation and material records within a GMP-regulated environment.
EDUCATION
Kutztown University College of Business
Bachelor of Business Administration - BBA, Management
Gies College of Business - University of Illinois Urbana-Champaign
Graduate Certificate in Financial Management Milestone toward Master of Management, Business Administration, Management and Operations
Lehigh Carbon Community College
Associate's degree, Health science
ABOUT OSCAR HERNANDEZ
I specialize in GMP (Good Manufacturing Practice) documentation and controlled document management within regulated pharmaceutical environments.At Sanofi, I support Third-Party Quality documentation by managing material specifications, processing supplier notifications, and supporting change control workflows to ensure compliance with regulatory and internal quality standards.My experience includes:• Document control and lifecycle management (Veeva Vault, SharePoint)• Specification writing and revision• Supplier documentation and cross-functional coordination• Change control tracking and compliance supportI focus on accuracy, traceability, and enabling operations to move forward through reliable documentation systems.
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