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The contract Document Control Specialist is responsible for managing and maintaining GxP-controlled documentation in compliance with regulatory requirements and internal quality systems. This role supports document lifecycle management and electronic document systems in a fast-paced biotechnology environment. The position plays a critical role in ensuring documentation integrity, audit readiness, and continuous quality improvement across the organization.
Job Responsibility:
Manage GxP-controlled documents, including but not limited to SOPs, Process Records, Work Instructions, Forms, Templates, Policies, Batch Records, and Test Records
Manage document collaboration, formatting, numbering, issuance, revision, and archival in accordance with established procedures
Process document change control requests through the Document Change Control (DCC) process
Track and manage periodic document reviews
Administer and maintain the Veeva Electronic Document Management System (EDMS)
Route documents for review and approval using DocuSign
Archive controlled documents in SharePoint and Veeva
Support training-related activities in Veeva
Assist with preparation, tracking, and presentation of document control and training-related KPIs
Provide document control or system-related training to staff
Support cross-functional teams by coordinating document collaboration
Contribute to audit readiness activities and respond to documentation-related inquires
Requirements:
Minimum of 2 years of experience in GxP document control within a pharmaceutical or biotechnology company
At least 2 years of hands-on experience managing documentation within the Veeva EDMS platform
Minimum of 2 years of experience working in a GMP-regulated environment
Strong organizational, prioritization, and planning skills, with the ability to manage multiple tasks in a fast-paced, team-oriented environment
Strong verbal and written communication skills
Proficient in working on a PC machine
Nice to have:
Experience supporting training administration in Veeva or similar LMS platforms
Familiarity with preparing or presenting document control or training metrics/KPIs
Experience delivering training or system overviews to cross-functional teams