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:

• 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