Gary Alexander Email & Phone Number

Assist Study Coordinator with Administrative Task.Collecting and organizing paperwork documentation, entering and updating study information into Oracle as needed.Performing quality control functions.Prepares and maintain test samples and related information for panel testing.Monitor the activities of study participants an responded to their needs.Remain alert to any issues that could impede the success of a clinical research study.

Act as ISOTrain Systems Administrator. Experience with course scheduling and registration, Maintain user tables, set/re-set passwords, liaison with Wyeth ISOTrain User's Group and site IT department. Enter employee training history, course updates, and module changes and maintain position curriculum and all associated regulatory audit trails. Query ISOTrain to track/trend performance indicators including training history/missing requirement and qualification reports for employees. Maintain system validation and perform system performance qualifications.Design and development training materials using solid instructional design skills in a variety of delivery methods in support of formalized training both classroom and one on one. Schedule and deliver new hire orientation.Change Control Coordinator to assure document control and document change control for procedures and job aids used for employee training/qualification/competency purposes.Perform duties in the role of GxPharma Coordinator/Approver ensuring all changes to cGMP documentation are in accordance with FDA, CFR, and other regulatory guidelines. And update site document Master database. Ensures that all biannual reviews and reports are accurate and up to date.Edit and format documents, proof read and revise SOP (Standard Operating Procedures). Maintain company record retention program both hard copy and electronically. A member of the Six Sigma team and Green belt certified. Team leader of Six Sigma projects within the distribution canter.Manage document files both electronically and in hard copy format. Provide secured backup of electronic files for immediate recovery.Create purchase orders for supplies and materials using SAP SRM 5.0 system.Served as a member internal audit team to conduct internal reviews of Standard Operating Procedures (SOPs)§ Maintain and edit Intranet website using WebBuilder software. Responsible for Qualified classroom and On the Job trainer.