Quality System Engineer

• Aug 2018 - Present

Quality Assurance Specialist

• Sep 2012 - Present

Supervisor, Software Quality Assurance & Training

• Jun 2010 - Sep 2012

Provide strategic and logistical direction for system testing, support, training and personnel to ensure quality of software systems.

Systems Training Coordinator

• Mar 2007 - Aug 2010

• Design and Develop Web-based and Classroom Materials for delivering systems training to internal and external customers• Create and implement curriculum planning for classroom and e-learning• Coordinate and deliver training to internal staff and external customers• Ensure consistency of training to assist with train-the-trainer workshops and other standardized instruction• Develop and report measures of success for training initiatives• Write user acceptance testing scripts for successful systems implementation Show less

Quality Systems Specialist

• Jul 1992 - Dec 2006

• Managed all quality systems and developed methods to achieve 100% metrics. • Assessed all discrepancies and evaluated the need for a formal investigation, monitoring the direction and quality of the investigation process. • Conducted investigations and authored investigation reports. • Performed trend analysis regarding key quality indicators for all quality systems, identifying areas of improvement. • Identified and streamlined workflow for quality systems by implementing global electronic systems. • Wrote and executed user acceptance testing scripts for computerized systems • Developed, reviewed and implemented new standard operating procedures • Responsible for life cycle management following 21 CFR Part 11 for GMP regulated documents • Streamlined activities between documents and electronic systems, improving efficiency by 50%. • Advised, consulted and coordinated activities with internal and external customers in regards to quality systems. Show less