Managed the Electronic Document Management system (Documentum) for controlled documents (Standard Operating Procedures, Job Aids and Forms); provided leadership; supervised 3 Document Control Specialists; assessed and implemented new technology; trained site users on system and procedures• Project Manager and Subject Matter Expert for electronic document system as pilot site• Decreased cycle time of revising documents by 40% through operational excellence and lean office concepts•… Show more Managed the Electronic Document Management system (Documentum) for controlled documents (Standard Operating Procedures, Job Aids and Forms); provided leadership; supervised 3 Document Control Specialists; assessed and implemented new technology; trained site users on system and procedures• Project Manager and Subject Matter Expert for electronic document system as pilot site• Decreased cycle time of revising documents by 40% through operational excellence and lean office concepts• Executed complete, thorough, and accurate reviews of all procedures to assure compliance to current Good Manufacturing Practices (cGMP) and company documentation practices• Designed, implemented process improvements resulting in reduced revisions and rework tasks to the documents• Created, implemented interactive, error proof electronic form to assure receipt of all required information needed for document revisions resulting in a 50% reduction of rejected submissions and increased first time quality• Implemented risk-based process for document periodic reviews which reduced number of documents needing review every 2 years by 40%• Designed, implemented Commitment Tracking Board which resulted in meeting more deadlines on time• Authored procedures, created training outlines, materials, assessments, and delivered computer and procedure training to site end users• Established good rapport with multiple departments, internal and external executives and customers while ensuring compliance with policies, procedures• Prioritized critical assignments, accomplished numerous assignments/deadlines accurately on time for regulatory inspections/audit commitments• Managed record retention program Show less

Assessed and implemented new technology; trained site users on electronic computer system• Devised business processes which resulted in transition from a paper document system to electronic system• Managed migration of 900+ documents 3 months ahead of target date• Participated on Corporate Design team as site representative for new electronic document management system

Managed paper document system for processing, routing, distributing, tracking, filing of controlled documents (Standard Operating Procedures (SOPs), Job Aids, and Forms); processed, distributed controlled documents and forms• Managed document distributions, maintained periodic review• Created Access database for tracking documents, created reports and forms to facilitate information retrieval when requested by other departments• Established a good rapport with controlled document… Show more Managed paper document system for processing, routing, distributing, tracking, filing of controlled documents (Standard Operating Procedures (SOPs), Job Aids, and Forms); processed, distributed controlled documents and forms• Managed document distributions, maintained periodic review• Created Access database for tracking documents, created reports and forms to facilitate information retrieval when requested by other departments• Established a good rapport with controlled document end users in providing document copies and by assisting in getting and keeping documents and end users up-to-date for compliance with company requirements Show less