GxP Documentation Specialist – Quality & Compliance

Sanofi; Swiftwater (Monroe County); On-site; USD 55,000 - 75,000; Full time

Job summary

Sanofi is seeking a Documentation Specialist in Swiftwater, PA to manage GxP documentation throughout its lifecycle, ensuring compliance with regulatory requirements and internal standards. The role collaborates across departments to keep content lean and up to date for inspections.

The ideal candidate has strong experience with CMS platforms, AI-assisted tools, and data-driven decision making, supporting audits and archival activities for the Swiftwater site.

Qualifications

• Bachelor's degree preferred.
• Minimum of 4 years of experience in document management, continuous improvement methodologies, and cross-functional process involvement.

Responsibilities

• Manage the GxP documentation lifecycle (creation, revision, obsolescence).
• Collaborate with other departments to ensure content meets business needs and processes.
• Ensure regulatory compliance and company standards in documentation content.

Skills

Verbal and written communication

AI-enabled tools

Analytical decision-making

Change management

Education

Bachelor's degree

Tools

CMS

Veeva Vault

Adobe Acrobat

Microsoft Office

Job description

Sanofi is seeking a Documentation Specialist in Swiftwater, PA to manage GxP documentation throughout its lifecycle, ensuring compliance with regulatory requirements and internal standards. The role collaborates across departments to keep content lean and up to date for inspections.

The ideal candidate has strong experience with CMS platforms, AI-assisted tools, and data-driven decision making, supporting audits and archival activities for the Swiftwater site.