GxP Documentation & Archiving Specialist

PharmaPayWatch; Swiftwater (Monroe County); On-site; USD 69,000 - 100,000; Full time

Job summary

Sanofi in Swiftwater, PA, is seeking a Documentation Specialist to manage the GxP documentation lifecycle and ensure regulatory compliance. You will collaborate across departments to maintain lean, accurate documentation while supporting audits and archival activities.

Strong knowledge of CMS tools (e.g., Veeva Vault) and AI-enabled workflows is highly valued. This role emphasizes cross-functional partnership, attention to detail, and effective documentation governance.

Qualifications

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

Responsibilities

• Managing the GxP documentation lifecycle (creation, revision, and obsolescence).
• Collaborating with other departments to ensure document content addresses business needs and processes.
• Ensuring regulatory compliance and alignment with company standards.
• Supporting audits and archival procedures for Swiftwater site.

Skills

Document management

Attention to detail

Communication

English proficiency

Education

Bachelor's degree

Tools

CMS (content management systems)

Veeva Vault

Adobe Acrobat

Microsoft Office

Job description

Sanofi in Swiftwater, PA, is seeking a Documentation Specialist to manage the GxP documentation lifecycle and ensure regulatory compliance. You will collaborate across departments to maintain lean, accurate documentation while supporting audits and archival activities.

Strong knowledge of CMS tools (e.g., Veeva Vault) and AI-enabled workflows is highly valued. This role emphasizes cross-functional partnership, attention to detail, and effective documentation governance.