MICHELLE ALMANZA

Document Control for Global Clinical Affairs Organization (GCAO) – Quality Management System (QMS) Windchill

Library for Clinical Study Documents

• Lead librarian - organizes, and manages all details related to the library
• Provides onsite and remote support, and training to GCAO
• Manages requests for appropriate Global Clinical Library access
• Creates and manages changes to training materials, references, and training manuals
• Provides Clinical Quality support to ensure documentation management compliance for clinical studies
• Creates, runs, and distributes reports as needed

Library for Clinical Quality Documents (Work Instructions, Templates and Forms)

• Initiates and manages COs for clinical documents through completion ensuring that COs are released by required date
• Reviews, proofreads and manages complex documents, spreadsheets and presentations requiring aggregation of support documentation for COs, and inputs from multiple Process Owners and Business Units
• Validates training audiences for documents that require training
• Clinical Training - Learning Management System (LMS)
• Provides onsite and remote support, and training to GCAO
• Creates and manages changes to LMS training and reference materials
• Creates and manages training audiences, audience assignments, and clinical training documents
• Assists leadership in defining training requirements and determines timelines to ensure clinical study training compliance
• Ensures training assigned is compliant per employee role and responsibility
• Reviews training audiences quarterly to ensure training activities and training audiences members are compliant
• Creates, runs, and distributes reports as needed

Inspection/Audit Support

• On site back room support for inspections/audits
• Creates, runs, and distributes Windchill library and LMS reports as needed for inspections/audits
• Investigates and provides justification for training inquiries

CAPA Support

• Execute COs within the timelines required to meet CAPA deadlines
• Creates, runs, and distributes Windchill library, and LMS reports as needed for CAPA support

• Piloted Windchill for document control purposes and successfully migrated TeamCenter documents to a clinical library in Windchill, included creating User and Librarian training manuals
• Processed revisions of documents in Team Center document control system
• Arranged and coordinated complex domestic and international travel
• Processed travel and expense claims, and submitted and reconciled expense reports for Directors
• Managed all department onboarding of new hires and off-boarding activities
• Maintained global email distribution lists as well as organizational charts
• Scheduled on-site and virtual meetings
• Organized all aspects for offsite conferences and external events