Documentation Specialist
: Job Details :

Position Overview: We are seeking a tech-savvy Documentation Specialist to support GI Development sites and activities, serving as the subject matter expert (SME) for electronic document management systems and facilitating the migration of records from legacy systems. This role requires high attention to detail, strong organizational skills, and the ability to manage multiple priorities with minimal oversight. Key Responsibilities:

Serve as the SME for electronic document management systems, including controlled and regulatory submission documents.

Create and configure document templates; support users in workflow configuration and routine system operations.

Act as the first line of user support for development teams utilizing document management systems.

Assist with records migration projects, transferring documents from original storage locations to approved document management platforms.

Follow detailed computer system instructions accurately and efficiently.

Manage multiple ongoing tasks while maintaining high-quality standards.

Collaborate with cross-functional teams to ensure compliance with regulatory and internal standards.

Produce clear and concise documentation related to system use and processes.

Preferred Experience & Skills:

Hands-on experience managing electronic document management systems, preferably within the Veeva suite in regulated lab environments.

Familiarity with Documentum, MS Teams, and MS SharePoint.

Knowledge of regulatory compliance and quality standards including:

21 CFR Part 11

Good Laboratory Practice (GLP) – FDA and EPA

Good Manufacturing Practice (GMP) – FDA and EU

VICH internal BI policies on Records and Training Management, and Information Protection.

Strong technical understanding of pharmaceutical and/or biological development processes and documentation is highly preferred.

Excellent attention to detail and ability to follow precise instructions.

Education & Experience:

Bachelor’s Degree with 2+ years relevant experience, or

Associate Degree with 2+ years relevant experience, or

Minimum 4 years relevant experience in electronic document management or related fields.

Education: Bachelors Degree