Documentation Specialist (AI)

Location: Swiftwater, Pennsylvania, United States

Company

R&D-driven, AI-powered biopharma organization developing medicines and vaccines while operating global manufacturing and supply systems.

What you will do

• Manage the GxP documentation lifecycle, including document creation, revision, periodic review, distribution, access, and obsolescence.
• Collaborate with cross-functional experts to keep documentation accurate, complete, compliant, clear, and free of unnecessary duplication.
• Support internal and external audits by maintaining retrievable, up-to-date records and documentation packages.
• Coordinate record retention and archiving activities for the Swiftwater site, including third-party storage vendors and annual archival eligibility reviews.
• Provide guidance and specialized training to CMS users, process CMS Care access requests, and issue high-priority Document Change Request reports.
• Support MOSAIC governance and the Fly paperless deployment program through project coordination, stakeholder communication, and document reconciliation.

Requirements

• Bachelor’s degree preferred.
• At least 4 years of experience in document management, continuous improvement methodologies, and cross-functional process work; pharmaceutical industry experience preferred.
• Working knowledge of content management systems and digital lifecycle platforms such as Veeva Vault.
• Proficiency with document management tools, Adobe Acrobat, Microsoft Office Suite, and related digital platforms.
• Excellent written and verbal communication, analytical decision-making, prioritization, and coordination skills.
• English proficiency required for verbal and written communication.

Nice to have

• Experience using AI-enabled platforms to streamline documentation workflows, automate routine tasks, and improve data accuracy and retrieval.
• Familiarity with intelligent search, automated classification, OCR, and generative AI for document drafting or summarization.
• Experience supporting paperless transformation, change management, dashboards, reporting, and system-generated analytics.

Culture & Benefits

• Supportive, future-focused environment centered on science, digital transformation, data, and AI-driven innovation.
• Career development opportunities through promotions and lateral moves, including international opportunities.
• Employee rewards and benefits programs with healthcare, prevention, and wellness support.
• At least 14 weeks of gender-neutral parental leave.
• Work contributing to medicine and vaccine delivery at global scale.