Manager, Quality Assurance and Regulatory
First Genetic Trust’s (FGT) web-based enTRUST ® Genetic Bank system enables pharmaceutical and biotechnology companies, medical research centers, and government-sponsored research programs to efficiently collect, manage, and analyze genetic and medical data.
• Responsible for maintenance of FGT’s Quality Management System. Preparation and maintenance of all company’s Standard Operating Procedures (SOPs), and related documentation. Ensuring highest quality levels of FGT’s entire scope of operations, with a focus on the delivery of quality products, and services.
• Implemented and supervised internal training program of all FGT’s employees with SOPs, 21 CFR part 11 Guideline, Computer Validation Systems and the knowledge of our products and our customers.
• Project Planning activities for the entire Software Development Life Cycle of enTRUST projects and Project Management for all Quality Management System related tasks, such as internal process improvement, audit preparations, etc.
• Review and approval of functional requirement specifications and design documentation.
• Supervision and direct involvement in all validation activities.
• Project Management and main user contact for all User Acceptance Test activities.
• Audit internal operations to ensure compliance with SOPs.
• Interview, hire, train and review performance of QA department staff members.
• Managed all client and vendor audit activities, as well as handling all audits performed at FGT by customers and third-party organizations.
• Recipient of the internal award for the 2004 project completion.

10/02-03/04 Sparta Systems, Inc Holmdel NJ
Manager, Quality Assurance
Responsible for the overall Quality Management System including QA/QC, documentation (technical writing), training and audit functions. Recognized subject matter expert on validation, specifically as it relates to 21 CFR Part 11. Internal trainer for Computer Systems Validation course.
• Preparing, reviewing, approving and deploying all SSI’s Standard Operating Procedures (SOPs) and Policies. Ensuring compliance with regulatory requirements by implementing standards and monitoring the process as required by diverse regulatory bodies.
• Authored Corporate Quality Manual, Software Development Life Cycle Policy, Unit testing, Code Review, Document Control, Change Control SOPs, etc.
• Successfully hosted audit by PDA, which the company passed without a single observation.
• Presenter at the 2nd TrackWise User Conference.
• Leading Project planning activities for computer systems implementations.
• Answering quality sections of RFIs/RFPs.
• Reviewing and approving all functional requirement specifications (FRS) and design documentation.
• Hands-on managed testing activities in an environment with complex system interdependencies.
• Managing the review, approval and maintenance of testing documentation including all test cases, deviation reports, and traceability matrices prior to productive release.
• Supervising team of QA Analysts responsible for testing TrackWiseâ products and overseeing the control and maintenance of user documentation such as Manuals, Installation guides, Application Notes and Release Notes.
• Hiring QA staff and responsible for training of all new hires.
• Responsible for software