QA Specialist

Job Description

POSITION SUMMARY:

The QA Specialist, Document Control is responsible for document management system use and end user support. The role manages document workflows within the electronic document management system, provides administrative approval for document promotion workflows, and provides inputs to document standards including formatting requirements. This position also aids with controlled document issuance, reconciliation and executed document archival.

This role is responsible for logbook issuance, executed batch record issuance, and coordinating client/ third-party approval for master and executed batch records.

This role is responsible for managing local document library, archiving records in accordance with the Controlled Index of Company Records (CICR) standards, and recall for executed records to support internal, corporate, third-party, and regulatory audits.

POSITION RESPONSIBILITIES:

Issue and Manage documents through various workflows in the electronic document management system

Ensure documents meet procedural requirements for formatting, training assignments, properties, and related meta-data

Issue/ recall official document prints including business continuity folders for the site

Manage physical document library, prepare records for archive per CICR requirements, and retrieve records as required

Deliver site-level end user support and training for the global electronic document management system

Serve as document author and SME for document management processes

Ensure Master Batch Records, Specifications, Laboratory Methods, Protocols, and similar cGMP documentation receive client/ third-party approval prior to implementation.

Complete logbook and executed batch record issuance activities.

Interface with cross-functional teams such as Operations, Training, Quality Management, Engineering, Maintenance, Supply Chain, etc. for Document Control functions supporting the site.