Michael Mah Email & Phone Number

Responsible for the preparation of software and equipment validation protocols and associated supporting documentation. Also serving as a project manager for the validation effort.

A contract resource to provide specialized assistance for the following projects.* Re-validate portions of an inventory system to communicate with tabletop and floor scales and label printers.* Implement and validate a laboratory computer system. Duties include:--- Author Computer Systems Validation documentation.--- Interface with various hardware and software vendors to communicate company's requirements.--- Assist the project team with test script creation and execution.* Validate computer controlling instruments.* Assist in the re-organization of laboratory data.

* Developed and performed data migration to new systems. Migrations included MS Excel to MS Access and Oracle to Oracle. Various technologies were used including classic ASP, VBScript, and MS Access.* Developed and created integration points between systems in the MS Access and Oracle environments utilizing MS Access and VBScript.* Interacted between IT and the business to ensure new systems will support the business process.* Analyzed systems to ensure updated business processes are met.* Developed and completed full computer system validation (CSV) that included Requirements, Design Specifications, Unit Testing, Installation Qualifications, Operational Qualifications, User Acceptance Testing, User Manuals, Change Controls, and Standard Operating Procedures (SOPs) following FDA Regulation 21 CFR Part 11 and the Software Development Life Cycle (SDLC).* Assisted various local and global project teams with exception and deviation resolutions during validation testing.* Interfaced with a vendor support team located in India to troubleshoot errors.* Designed and implemented an application training curriculum.* Provided user and administrative training to various business and IT users.* Supported the GMP inventory and supply chain systems including POMS, Clinicopia, and custom systems.

* Managed the creation of the Laboratory Segregated Network.* Managed the Chromatography Data System Replacement project.* Primary support for GMP inventory systems.* Assisted in the implementation of a finished, shippable goods system for the Clinical Supplies Packaging business unit.* Assisted in the validation of various applications used in the Clinical Manufacturing business.* Designed and developed a web based reporting application using classic ASP interfacing with Oracle and MS Access databases. The report output was in Crystal Reports, Excel, and text files.* Designed and implemented a web based scheduling system in classic ASP. This system read Microsoft Project files from various projects and displayed the resources used for all projects in a calendar.

* Authored the Installation Qualification of the POMS GMP inventory system.* Interfaced with the POMS vendor to troubleshoot errors in the application and to identify and create new custom functionality to meet the users' requirements.* Assisted in the development of the Operational and Performance Qualifications.* Assisted in the development of the custom reporting application for the POMS system written in VB6 with Crystal Reports 7.5.* Managed technical consultants.* Implemented off the shelf applications for GMP use.

* Maintained and customize an Omnis 7 timekeeping application.* Assisted in a PeopleSoft 7 implementation (focusing on Accounts Payable and Purchasing) and the PeopleSoft 7.51 upgrade.* Maintained the PeopleSoft Oracle 7 database.* Created Microsoft Access 97 Database applications.* Provided desktop support.* Administered the phone system.* Provided backup server and network administration.* Routed network and phone cables.

While in school, I created and operated Softek, a computer design and consulting company, specializing in computer hardware for home and small business users.