Description
Administer and enforce enterprise document control, managing the capture, review, approval, distribution, revision, retrieval, and disposition of controlled documents and records in compliance with regulatory and company standards.
- • Assess departmental needs for controlled documents, workflows, and retention.
- • Monitor regulatory and quality standards (e.g., ISO, FDA, SOX) to keep document control processes compliant.
- • Develop and execute validation and user acceptance tests for document control systems.
- • Search repositories and archives to locate current, approved versions of controlled documents.
- • Issue, track, and reconcile controlled copies and transmittals to stakeholders.
- • Recommend improvements to numbering schemes, templates, workflows, and tools.
- • Create SOPs, work instructions, and training for document control and end users.
- • Enforce security, access, and distribution rules for controlled documents.
- • Oversee scanning and indexing of paper or legacy controlled documents.
- • Document business requirements and configurations for document control systems.
- • Define and maintain document control policies, standards, and naming conventions.
- • Resolve user issues with access, permissions, and version conflicts.
- • Define metadata and classification to support search and retrieval.
- • Support selection, configuration, and rollout of document control software.
- • Establish and maintain change control, approval, and distribution policies.
- • Track and report cycle times, approval metrics, and audit results.
- • Import, index, and release new and revised documents; maintain master records.
- • Administer permissions, versioning, and revision control for master documents.
- • Partner with IT to implement e-signatures, workflows, and controlled distribution.
- • Classify documents by type, confidentiality, lifecycle stage, and retention.
- • Configure user roles, approval routes, watermarking, and document workflows.
- • Stay current on document control standards, regulations, and tools.
- • Process change requests, publish revisions, and obtain required approvals.
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Last reviewed: Jan 2026