QA Associate I - Document Control - (Bedford, NH)

POSITION DETAILS Manage, coordinate, and maintain CGMP documentation, procedures, and records to ensure only controlled copies are reviewed, approved, issued, distributed, and archived. POSITION RESPONSIBILITIES Maintain DCR/Quality system event databases and Master Documents / List Maintain Designated Satellite Areas for controlled paper based record management system Create Labels as needed Facilitate Client Batch Record Creation / Modifications / Approvals Issue and Archive Batch Records / Testing Data Capture Sheets / Lab Books / Equipment Log Books / Room Log Books/Quality system event documents Facilitate Biennial SOP reviews Maintain Document / Material / Batch Numbering Logs Obsolete Documents Manage Record / Document Filing system Proof and edit document changes, if necessary Assist with Line Clearances (Backup capacity) Assist in audit preparation and reconciliation Other duties as assigned EDUCATION, PROFESSIONAL SKILLS, BACKGROUND MINIMUM QUALIFICATIONS