Documentation Specialist

Main Responsibilities

• Manage the GxP documentation lifecycle (creation, revision, obsolescence).
• Collaborate with other departments to ensure documentation addresses business needs and processes.
• Ensure documentation content is compliant with regulatory requirements and company standards.
• Keep documentation packages lean (avoid redundancies/duplication).
• Ensure documentation accuracy, completeness, and compliance with writing rules (clarity/grammar).
• Collect documentation change needs; prioritize and manage updates.
• Ensure documents remain current and aligned with evolving needs/processes.
• Ensure document distribution and access comply with information classification level.
• Support internal/external audits and inspections by ensuring documents are up-to-date and retrievable.
• Support record retention archiving procedures as a Business Archives Coordinator (BAC) for the Swiftwater site.
• Liaison with approved third-party storage subcontractors; provide guidance on archiving tools/processes.
• Support annual archival eligibility reviews.
• Serve as backup CMS Community of Practice (CoP) representative; participate in Centers of Excellence (CoE) when requested.
• Support CMS user training, access management (CMS Care requests), and weekly high-priority Document Change Request (DCR) reporting.

• Bachelor’s degree preferred.
• 4+ years of document management, continuous improvement, and cross-functional process involvement (pharma preferred).

• Experience with digital tools and AI-enabled platforms to streamline workflows and improve accuracy/retrieval.
• Working knowledge of CMS and digital lifecycle management platforms (e.g., Veeva Vault).
• Familiarity with AI-assisted document processing (intelligent search, automated classification, OCR, generative AI).
• Comfort with paperless/digital transformation (Fly, MOSAIC); support change management.
• Data literacy; interpret dashboards/reports.
• Proficiency with CMS, Adobe Acrobat, Microsoft Office, Veeva Vault.
• Strong communication, analytical problem-solving, decision-making; manage multiple priorities.
• Ability to evaluate/pilot/champion AI and automation solutions.

• English required (verbal and written).