Admin for site LIMS systemCreate and execute change controls for site master dataDay to day site support Site audit support Project support for LIMS

Global LIMS Owner - LabVantage LIMSAssisted Local QC Business with Master Data ConfigurationAssisted Local QC Business with defining lab processesAssist Local QC Business with Instrument InterfacingAssist with troubleshooting LIMS IssuesAssist off shore resources with question/issuesRevise, approve URS documentationReview, approve FRS documentationReview SDD documentationReview, approve IQ documentationWrite, dry run, review, approve, execute test casesWrite, review, approve OQ ProtocolsReview Support Run Book documentationAssisted with Validation of a Global SpreadsheetCurrently working on LabVantage Upgrade Activities

LabWare LIMS (Laboratory Information Management System) Subject Matter Expert (SME)Participate on all LIMS projects Currently working on LIMS v6 upgrade Configure static and master data within the LIMS Conducted Conference Room Pilots and led the users through the system Assist IT Development with design of systemAssist with Validation of LIMS projects Assist with creation and review of URS/FS Assist with writing and execution of test scriptsAssist with troubleshooting LIMS issues Assist the LIMS team with troubleshooting of day to day LIMS issues Assist the LIMS off-shore resources with questions / problems Point of contact for users when issues ariseLabware LIMS trainer for the site Currently LabWare LIMS v5 Working with the GxP Training team to build training materials for LIMS v6Computer Training:SQL Level 1Crystal Reports Level 1Certified Labware LIMS v6 AdministratorLIMS Basic Training (LabWare)

Raw Materials Supervisor and Interim Quality Standard ManagerSupervise raw materials group-responsible for day to day scheduling of assigned Quality Control personnel to meet testing cycle times and commitments for raw materials and packaging componentsInitiate and manage Planned Deviations and LIRs associated with raw materials group in SAPRevise SOPs in QDCS systemCreate new and manage revisions to Quality Standards in SAP, LIMS, and QDCS

ChemistPerform testing on bulk raw materials according to USP, NF, EP, and in-house proceduresPerform dissolution and assay testing on finished product and stability samples according to specified methods

Chemist in the raw materials laboratory

Performed testing on bulk raw materials according to USP and NF proceduresPerformed dissolution, content uniformity, and assay testing on final product and stability samples