Description
Manage document control for the quality management system, coordinating creation, review, approval, distribution, and retention of SOPs, work instructions, forms, and quality records. Support audits and change control, maintain training and documentation databases, and ensure all quality documentation meets applicable standards and company policies.
- • Advise teams on document control requirements and change control impacts.
- • Coordinate creation, review, approval, and controlled distribution of SOPs, work instructions, forms, and quality records.
- • Maintain the document control system, including versioning, change history, permissions, and master lists.
- • Ensure quality documents comply with applicable standards (e.g., ISO, GMP) and company policies.
- • Prepare, format, and edit documents for clarity, consistency, and correct metadata.
- • Schedule and track periodic document reviews and re-approvals.
- • Administer training assignments and maintain training records linked to controlled documents.
- • Coordinate cross-functional reviews and approvals in the eQMS/DMS.
- • Compile and maintain quality documentation repositories and indexes.
- • Determine required documents and records for new products, processes, or changes.
- • Review labels, batch records, specifications, and test methods for correct versioning and approvals.
- • Develop and deliver training on document control procedures and tools.
- • Obtain and distribute updates to standards, templates, and procedures.
- • Maintain current knowledge of documentation-related regulations, standards, and guidance.
- • Prepare audit-ready documentation packages and evidence matrices.
- • Support internal and external audits by providing requested documents and tracking requests to closure.
- • Prepare and coordinate responses to auditor or customer documentation requests and questionnaires.
- • Prepare and maintain quality files and master records as required by the QMS.
- • Write or revise SOPs, work instructions, forms, and document control policies.
- • Recommend and implement improvements to document workflows and templates.
- • Develop and report quality documentation metrics (e.g., cycle time, on-time review, training completion).
- • Manage controlled copies and archival of obsolete documents per retention requirements.
- • Support CAPA, deviations, and change requests with accurate records and attachments.
- • Coordinate documentation for recalls, market withdrawals, or field actions as needed.
- • Provide pre-, during-, and post-audit documentation support and follow-up.
- • Log and route product complaints and ensure related records are complete and current.
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Management & Entrepreneurship
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O*NET occupational data (work activities, skills, knowledge).
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Last reviewed: Jan 2026
