OBJECTIVE
To continue a rewarding career in software verification and validation at a leading technology company.
SOFTWARE APPLICATIONS ADMINISTRATOR *****.*********.*****@*****.***
COOK MYOSITE INC • AUGUST 2015 - PRESENT
-Perform 21 CFR Part 11/Annex 11 gap analyses on software systems.
-Develop user requirement specifications, functional specifications,
design specifications, test scripts, and standard operating procedures
(SOPs) for custom client-server databases (front-end and back-end).
-Develop user requirement specifications, functional specifications,
design specifications, test scripts, and standard operating procedures
for a web-based electronic Quality Management System (MasterControl).
-System maintenance and administration for custom databases and a web-
based electronic Quality Management System (MasterControl).
-Designing and writing test scripts to evaluate software systems
against design, functional, and requirement specifications using the
following: white box, integration, and regression testing.
-Assist with black box validation testing to evaluate software systems
against design, functional, and requirement specifications.
-Design an Engineering Quality System with policy documents and SOPs.
-Gather user requirements for custom databases and MasterControl.
-Manage projects relating to the development lifecycle for custom
databases and MasterControl.
QUALITY ASSURANCE ASSOCIATE • COOK MYOSITE INC • JULY 2012 – AUGUST 2015
-Reviewed product batch records in preparation for approval.
-Led and conducted internal audits into various quality systems.
-Reviewed white box and black box validation documentation for software
systems.
-Reviewed validation documentation for equipment such as incubators,
temperature sensors, pipettes, and other equipment used in
manufacturing a sterile biologic product.
-Wrote and approved investigations into product/process deviations.
EDUCATION
B.A. CHEMISTRY • 2012 • ASBURY UNIVERSITY
GPA: 3.2
National Scholar Honors Society
Sigma Zeta Math and Science Society