Goal-oriented professional with 20 years of experience in Quality Documentation with highly qualified skills in the following areas: Human Error Reduction, Compliance, Computerized Data Support and Analysis, Distribution, Documentation Auditing, FDA Approval and Audit Process, Graphical and Data Reports, Policy/Procedure Creation and Revisions, Problem Resolution, Project Management Training and Development. Results oriented, self-starter, adapts well to changing priorities, and effectively manages direct reports and internal and external client relations.
Customer Relationship Management
Training & Development
Microsoft Word, Excel, PowerPoint and Visio
Cognos and Powerplay
GPO Global QA Documentation Supervisor January 2011 to CurrentAbbVie Inc － Waukegan, IL
Provide direction and leadership to the division for the development and implementation of systems used to control divisional change control.
Develop staffing requirements and as business needs arise, hire and train contract staff to support business needs.
Manage document cycle time and distribution strategy to support product launches and prevent shut down situations.
Supervise/manage exempt and contractor employees and ensure training and development plans are current and executed.
Drive process improvements within AbbVie Operations, i.e.
Human Error Reduction during Change Request processing.
Manage various complex divisional and departmental projects.
Acts as Operations coordinator for changes to systems and processes to determine the impact of changes to related systems and databases.
Consult with initiators to expedite Change Requests and minimize First Pass Acceptance and Data Integrity errors.
Develop and report Operations metrics / KPIs to organization.
Leading the InfoMapping Team and implementing a new tool for document authoring with SMEs.
Doc Editor 1 May 2010 to February 2011Abbott Laboratories － Waukegan, IL
Demonstrates management functions of supervising, leading, planning, and organizing.
Initiate, manage and execute projects to continuously improve the overall effectiveness of the department.
Provide direction in the system requirements, system test development and execution of validation.
Coordinate with multiple functional areas and sites to implement product Change Requests.
Develop and lead the 5S team for Operations.
Documentation Change Coordinator March 2007 to May 2010Abbott Laboratories － Waukegan, IL
Evaluate the content of change request packages.
Ensure required policy requirements are present, form is filled out accurately and current Good Manufacturing Practices are met.
Update and maintain quality assurance procedures and databases.
Subject Matter Expert for Global Distribution System (GDS) and Electronic Change Request (eCR) database.
Enters updates to the Corporate Purchasing Specification Tracking System (STP) for purchased materials used in the manufacture of Abbott products.
Approves UNIX authorization forms for division.
Document Process and Systems Specialist Coordinator January 2002 to March 2007Abbott Laboratories － Waukegan, IL
Provided computerized data support, system interfaces and analysis to management and other divisional departments to assure timely reporting of data and technical information, and appropriate analysis of key data points and trends, with associated recommendation and follow-up.
Analyzed and streamlined distribution process for division with other Abbott divisions, third parties and other external customers.
Created, implemented, and distributed metrics to management and other designated individuals to communicate division CR progress monthly.
Standardized procedures and implemented impact assessment activity for new/revised corporate level polices.
Ensured divisional Subject Matter Expert feedback was forwarded to owning division.
Senior Specification Technician June 1996 to January 2002Abbott Laboratories － Waukegan, IL
Responsible for division documentation distribution with associated process management for internal and external users.
Provided technical, administrative, analytical and managerial support to the quality assurance organization.
Created and revised procedures based on changing business processes and needs.
Entered critical information into current documents using Document Management System (DMS).
Coordinated and incorporated changes to documents pending FDA approval.
Education and Professional Training
Masters of Art : Management & LeadershipWebster UniversityManagement & Leadership
Bachelors of Art : Psychology/Criminal JusticeColumbia College of MissouriPsychology/Criminal Justice
administrative, business processes, Cognos, content, Customer Relationship Management, databases, database, direction, Document Management, documentation, FDA approval, forms, functional, leadership, managerial, materials, Excel, PowerPoint, Microsoft Word, organizing, Powerplay, processes, process management, progress, Project Management, Purchasing, quality assurance, reporting, Specification, staffing, strategy, supervising, UNIX, validation, Visio