Documentation Specialist

Job Summary

A company is looking for a Documentation Specialist to support GI Development sites and activities.

Key Responsibilities

• Serve as a subject matter expert for electronic document management systems and assist in the migration of records from legacy systems
• Create and configure document templates and provide user support for electronic document management and regulatory submissions
• Support records migration projects and manage multiple ongoing activities with minimal oversight

Required Qualifications

• Bachelor's Degree with 2 years of relevant experience, or an Associate's Degree with 2 years of experience, or 4 years of relevant experience
• Demonstrated experience managing electronic document management systems, preferably in a regulated laboratory environment
• Familiarity with Veeva, Documentum, MS Teams, and MS SharePoint is preferred
• Understanding of pharmaceutical and biological development processes and documentation
• Knowledge of 21CFR Part 11, GLP, GMP, and internal BI policies on Records Management