Skills: Microsoft Office Products, Novell Software, Lotus Notes, Adobe Acrobat and Photoshop, PDF Writer/
Composer, eSubStand10, Corel Print House, Serif Graphics Plus, Oracle, Symantec Act, Sigma Plus, AS400, eQCM, Documentum
• Criminal Justice, Philadelphia Community College, Philadelphia, PA, 1979
• Network Engineering Technology Administration, Computer Learning Center, Plymouth Meeting, PA, 2000
Nu Ark Productions, Pottstown, PA 12/10-Present
• Create and design graphic artwork for sale to the modern business and home.
• Art Gallery can be viewed at http://nuarkproductions.com.
• Employ Adobe Photoshop, Microsoft Word and PowerPoint; Picture Perfect, HP Quick Play, Windows Movie Maker, Ark Soft Panorama Maker, and Creator Basic.
TechUSA/Synthes, West Chester, PA 09/10-12/10
• Create and revise controlled documents.
• Administration of the Document Change Order process with timely releases of new and changed documents.
• Prepare and review documents for input into Manuscript and Intralink document control systems.
• Generate and distribute Document Change Orders release notifications.
• Image and store Document Change Orders in databases.
• Process and close Nonconformance records, Manufacture and Machine batch records, First Article Inspection reports and trace and store product inventory reports.
Inteprod LLC, Eagleville, PA 01/10 – 6/10
Quality Assurance Assistant
• Develop, implement and maintain Quality Management System requirements on assigned areas of Manufacturing, Supplier Management, Process Validation and New Product Introduction including Non-Conforming Product, CAPA, Supplier Management, Inventory, and Document Auditing, Training on working documents, Quality Planning, Protocols, Facilitation of Root Cause Analysis, Risk Assessment and Complaint Investigation.
• Create, manage, update, distribute and track Device Master Records, Device History Records and Project Master Document Records in the Quality Management System as prescribed by company procedures derived from the FDA requirements of the Quality System Regulation, Subpart D – Document Controls, 820.40 and ISO 13485 Standards that govern SOP’s in the Medical Device field.
• Prepare monthly reports of QA performance activities and administer tracking activities necessary to support ongoing compliance.
• Verify documentation from manufacturing builds prior to filing with document control.
• Standardize templates as necessary.
• Assure Document Control Department updates all records with proper revisions, obsolescing retired documents, distributing current documents in their correct locations, and prepared for audits weather internal or external.
Sanofi – Aventis, Malvern, PA 07/04 – 12/05
Clinical QA Coordinator
• Provided technical software support for the scientific group.
• Assisted with the preparation of summary documents appropriate for submission to regulatory bodies.
• Performed quality checks for Metabolism and Pharmacokinetic report.
• Applied logical and structured approaches to electronic file management.
Aventis Behring, King of Prussia, PA 06/01 – 12/02
• Provided secretarial, administrative, and technical software support to the Regulatory Affairs Vice President, Regulatory Directors, Senior Regulatory Managers, and all Senior Regulatory Associates.
• Produced and maintained electronic drug products and regulatory reference libraries, databases, and indexes for FDA submissions using Access, Excel and PDF Writer/Composer.
• Proofread drug packaging components, advertisements, and promotional pieces while also tracking electronically all the proper revisions utilizing Excel and Project Management.
• Produced word documents for drug package inserts and drug product monographs as well as help make revisions of art graphics for drug labels.
• Managed executive’s calendars, booked appointments, conference calls and events.
• Made travel arrangements and prepared and maintained expense accounts.
• Screened all calls, directing them to their appreciate destinations.
• Prepared office correspondence, reports and presentations using Word, Excel and Power Point.
RCN Telecom, Trooper, PA 01/99 – 06/01
• Provided administrative support for the Commercial Sales Office consisting of a Regional Sales Director, Sales Managers, Order Managers, and Commercial Account Sales Executives.
• Arranged all business travel, seminars, and training exercises.
• Arranged conference calls, meetings, events, luncheons, and parties.
• Negotiated contracts with supply vendors for inter departmental needs and outside group activities.
• Prepared and maintained all department expense accounts.
• Assisted Sales Director in the hiring and terminations of department employees.
• Created and maintained confidential employee files and customer files.
• Prepared reports and presentations using Word, Excel, and PowerPoint.
• Assisted in call center activities identifying customer issues pertaining to local and long distance telephone lines.
• Documented customer problems and their appropriate resolutions.
• Assembled statistics to composed weekly, quarterly, and year-end sales report.