Must Haves :

• High School or Associate’s degree with 3-5 years relevant experience or Bachelor’s degree with 2-3 years relevant experience or Master’s degree with 1-2 years relevant experience.
• Proficient in Microsoft Office software (Word, Excel, PowerPoint)

Plusses :

• Experience executing transactions in a Document Management System
• Experience conducting classroom and on-the-job training sessions
• Experience with proofreading / formatting documents

Job Description

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 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.

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.

Last updated : 2024-05-21