- Performs review of cGMP documents in EtQ in preparation for Department/Technical, QA, and client (if applicable) review and approval.
- Communicates with the client regarding document review and approval and updates to the cloud, if applicable.
- Represents Document Control on project-related teams and assists with Production deliverables.
- Supports internal audits, client audits and regulatory inspections.
- Controls issuance, receipt, and archival of cGMP documentation.
- Maintains controlled forms (logbooks, etc.) for applicable departments.
- Fulfills documentation requests from internal and external customers.
