§  Software Validation / Verification: Concept/Proposal Documents, Validation Plans, User and Functional Requirements Specifications, Risk Assessment Reports, Software Design Specifications, IQ/OQ Documentation, Test Protocols and Test Reports

o    Medical Device software

o    ERP (Enterprise Resource Planning) Systems

o    EDM (Enterprise Documents Management) Systems

o    Preventative Maintenance Systems

o    Labeling Software

o    Telecommunications software

o    Software Developers (API level)

§  RFP & Proposal Writer: Ten years of Request for Proposal and proposal response writing experience (resulting in individual contracts of over 1 million dollars)

§  SOP & DOP: Generation and revision of operation procedures for quality assurance purposes

§  Work Instructions: Develop work instructions specific to customer use of software application

§  FDA 21 CFR Part 11: Developed evaluation and remediation planes for guideline compliance

§  Sarbanes Oxley: Computer systems audit and remediation using industry best practices standards

§  Audit Remediation: Worked with QA and Regulatory Affairs to remedy audit findings 

§  Business Process Flow Mapping: Proficient with developing current and optimal state business process flowcharts

§  Gap Analysis: Perform system and software gap analysis for fiscal decisions

§  Presentation Developer: Robust PowerPoint presentations

§  Workflow & Process Diagramming: Visual diagrams of workflow and process flow for development and documentation purposes.

§  Technical Manuals: User guides, Service Provider Manuals and Release Notes

§  Training Program Development: Created and proctored hardware & software training

§  Project Manager: Liaison between software developers, all levels of management and staff for company-wide software transition

§  Read and write in HTML, VB and Java code

 "I am a proven achiever who can get the job done. I have both the technical skills required to understand complex systems, and the people experience to achieve results."