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:
- Bachelor's 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