QA Documentation Specialist - III

Responsibilities:

• Ensures the correct and timely implementation of Change Requests (CR), Document Change Orders (DCOs) and Documents.
• Maintains documentation manuals to ensure accuracy and current information.
• Ensures the correct and timely input of database entries, verifies own work.
• Supports the distribution and maintenance of GXP documentation.
• Scans, verifies and archives documentation as needed
• Recommends process improvements and proposes changes.
• Provides support with internal and regulatory audits/inspections as required.
• Provides user training for electronic systems (as applicable).
• Creates and maintains document templates.
• Assists with the periodic review process.
• Supports the maintenance of monthly document control metrics.
• Performs general word processing tasks and support.
• Checks format and conformance to document templates, verifies own work.
• Provides additional support and assistance on tasks and projects as directed by management.
• Participates as required in training on issues affecting own area of work.
• Notifies manager of compliance questions and issues.