Document Controller

Document Controller needs f 4 years of experience in document control within a regulated (GxP) pharmaceutical or biotechnology environment

Document Controller requires:

• Demonstrated hands-on experience managing controlled documents using Veeva QualityDocs (required)
• Experience supporting inspections audits periodic reviews and documentation gap assessments Educational Requirements:
• Bachelors degree or equivalent experience
• Strong written and verbal communication skills
• Detailed knowledge of Quality policies procedures and document control principles
• Strong attention to detail organizational skills and ability to manage multiple priorities
• Proven ability to work independently and influence across functions

Document Controller mist duties:

• Owns and manages the end-to-end document control lifecycle for QA documentation including creation revision review approval issuance archiving and retirement in compliance with GQS and LQS requirements
• Provides subject matter expertise on document control standards processes and best practices to QA and cross-functional partners
• Reviews QA documentation for accuracy completeness formatting and compliance with quality standards and regulatory expectations
• Leads and supports periodic review and gap assessment activities identifying documentation gaps risks and remediation needs
• Coordinates and facilitates document routing through electronic or manual review and approval workflows ensuring timely execution
• Maintains controlled document repositories to ensure documents are current traceable and readily accessible for operations and inspections
• Tracks monitors and reports documentation status metrics and deliverables to QA Operations leadership
• Supports inspection readiness activities by ensuring controlled documents are inspection-ready and aligned with site practices
• Partners with QA and operational stakeholders to support documentation strategies for new processes changes and remediation efforts
• Identifies opportunities to improve document control efficiency consistency and compliance