Document Control Specialist
Responsibilities:
- 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 QS 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.
Minimum Experience Requirements:
- Minimum of 4 years of experience in document control within a regulated (GxP) pharmaceutical or biotechnology environment.
- 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.
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