Daniel Hardy Email & Phone Number

Irvine, California, United States

Managed several Quality Management System upgrades and shift to SaaS. Managed Validation System major upgrade in preparation for shift to SaaS and managed Supplier Management System shift to SaaS. Designed & Delivered:An engaing UI/UX that acts like an interactive Visio chart of an Enterprise Architecture allowing the user to see the architecture reveal.

Irvine, California, United States

Upgraded the Hardware and made several point increment and major version upgrades of the QMS System in preparation for Shift to SaaS. This had the immediate benefit of better performance and system stability. Once stable and SaaS capable, lead the successful migration to the cloud. Made many fixes and enhancements in the configurable scripting code to be.

Fullerton, California, United States

Leading a team of developers in the development of custom software applications by working cross-functionally with business partners, end users, and the executive team members to create dynamic applications that are scalable, support organizational objectives, promote business innovation, and enable new thinking.

Irvine

DevelopedExcel macro that graphically highlitghed the technological pathways from User portal front end to distributed middleware and back end systems based on the parameters in the Agile release in question. This allowed a quick review of affected front end, middleware, and backend systems out of more than 200 systems available on the gloabl.

Irvine, CA

Developed Excel tools for checking Jira artifacts against testing requirements and Confluence documentation for Release Management Approval.Improving the quality of global cross domain/platform Product releases in a dynamic Agile environment, by mapping systems and services and ensuring all touch points are thoroughly tested and traceable to business.

Brea, CA

• Roles: Business Systems Analyst, Software Developer, Applications Architect, Project Manager, TrainerTransformed manual processes into efficient automated solutions. Managed large scale global enterprise-wide.
• Delivered within 1 week a SPA UI/UX matching Customer's sketch, utilizing Restful API Calls for UDI search from other systems.
• Successfully developed a system to upload over 3 million records of sales records received as Excel worksheets from a newly acquired company into a custom database to allow querying and reporting for recall purposes.
• Achieved no loss of production capability while completing a 9-month global replacement of the legacy EQMS System supporting 14,000+ users around the world.
• Lead a cross-functional team of process owners, and SMEs across various departments and sites for the implementation of the GAMP5 21 CFR Part 11 compliant CAPA and Complaint Modules including User.
• Created an automated test script writing tool to maintain validation format and ease repetitive task step inclusion. Made data-based requirements gather tool that would aid in test script generation and Trace Matrix.

Ensured that Biometric Identification Systems used by Law Enforcement, Military, and Intelligence agencies matched system schematics and operated according to system requirements. Worked on systems supporting the FBI's NGIS (Next Generation Identification System replacement for AFIS), also for SPAWAR and DIA. Inspected OEM Mfg sites, and made monthly.

Responsible for gathering user requirements and creating custom Quality Systems for companies regulated by the FDA and notified bodies. Custom configuration of CATSWeb including custom.dlls. to allow GB size file uploads, integration with SAP, AGILE, ORACLE etc. Designed Complaint, CAPA, Non-Conformance, and Inspection Processes. Worked extensively with.

Buena Park, CA

• Managed the manufacturing quality support functions of over 1 billion dollars worth of OTC Drugs and Vitamins per year at ABG while managing a staff of over 20 direct reports distributed in 6 laboratories in various.
• Won a lucrative multi-million dollar OEM Pharma Contract by delivering a wireless intranet based instrument interfacing systems for capturing production and lab data that created real-time statistical charting and.
• Developed a Web-based UI/UX program linking ERP and LIMS information to eliminate unnecessary testing of over 1 billion dollars’ worth of OTC Drugs and Vitamins per year.
• Designed a user-configurable Intranet such that cross-functional Green Belt teams could post: free text, files, images, or video clips. This allowed the posting of SOPs with video clips for training purposes. Users.

Ba, Biology

Mba-Technical Management, Information Technology/Business Administration