6507 - Document Controller / Associate CQV Engineer

Manage the creation, routing, review, approval, issuance, revision, and archival of controlled documents within the electronic document management system (EDMS).

Utilize Veeva to manage document workflows, approvals, revisions, and document lifecycle activities.

Ensure controlled documents are accurate, current, properly formatted, and maintained in accordance with established procedures and cGMP requirements.

Support document control activities for SOPs, work instructions, specifications, protocols, reports, forms, and other GxP documentation.

Coordinate document reviews and approvals with Quality, Engineering, Validation, Manufacturing, and other stakeholders.

Track documents through the approval process and follow up with document owners and reviewers to ensure timely completion.

Maintain document histories, revision records, effective dates, and appropriate archival of superseded documentation.

Perform quality checks of documentation for completeness, accuracy, formatting, and compliance with Good Documentation Practices (GDP).

Assist with document retrieval and preparation for internal audits, regulatory inspections, and project activities.

Support continuous improvement of document control processes and procedures.