Orange County, California, United States
Focused with self initiative
Coordinates PM/re qualifications of lab instruments with the vendors and laboratory
Laboratory Systems Administrator responsible for LAC/E boxes weekly rebooting. Provided help and support to lab analysts with their interaction with the applications of computerized systems: e.g., application administration, account creation, deletion or modification, password reset, project archival/restore, archival of closed reports, connection issues and application interaction support. Helped with investigations on lab. system failures to determine the root cause of failure and software issues (disconnections, inconsistent results, etc.), and completed the IT part in TrackWise. Provided configuration support of existing systems: UPLC, HPLC, GC, etc. Supported CSV with the validation of computerized systems as executor and author of CSV documents (worked with end-users, lab management, and CSV senior engineer to define roles and access requirements, Risk assessments, URS, etc.) and proof-reading issues. Author of administration SOPs for IT department in MasterControl. Excellent expertise administering and troubleshooting of Empower3, ChemStation, WinSotax, Tiamo, Agilent Cary 60 WinUV and other GMP software used in the laboratories. Prepared and updated configuration drawings
Laboratory support analyst, IT department
Administrator of Lab. Systems working with the IT Group to ensure all LAC/E boxes are rebooted on a weekly basis every first day of the week. Also, to continually help lab analysts with their interaction with the applications of computerized systems: e.g., Account creation/deletion, password reset, project archival/restore, archival of closed reports and connection issues and application interaction support. Responsible for helping with lab. System failure investigation to determine the cause of failure and helping on the configuration of the systems. Aditionally, Helping with the computerized system validation. Excellent expertise working with Empower 3, ChemStation, WinSotax and other software used in the laboratories.
Responsible for dietary supplement method development and validation as well as for mentoring junior chemists in the use of HPLC, GC, FTIR, pH meter, ICP-OES, etc. Purchasing coordinator for supplies for the QC lab. Troubleshoot and maintenance of lab equipment, and for scheduling annual requalification of equipment with outside contractors. Responsible for writing and revising SOPs, protocols, and reports. Participate in internal audits in the QC lab to improve compliance, and revision of lab notebooks after the analysis had been complete and checking it for completeness and compliance. Helped QA department with investigations of out of specification investigations.
Primary responsibility was collection of samples for testing of raw materials and finished products by HPLC, GC and ICP-OES analysis. Lab supplies purchasing coordinator while maintaining a good inventory of chemicals and lab supplies and labelling and storage. Responsible for maintaining, and qualifying equipment in the QC lab as well as microbiological assay of raw materials and finished products making sure they complied with the specifications.