Supervisor, QA Batch Record Review and Release Resume Example

Managed the QC sample control and administration group and the Laboratory and Information Management Systems (LIMS) group. Reviews and approve SOPs related to the department. Assist in compliance audits as required and participates and helps provide answers during FDA and internal Novartis audit, handles investigations/deviations associated with sample administration and LIMS related issues, supports the Standard Coordinator with Standards inventory management/proper storage, manages glassware availability for the whole laboratory ; handles the issuance of validation document number and oversees management of QC documents prior to permanent archival, had worked with the QC Scheduler to track and trend laboratory performance and operations through lab metrics, and oversees compliance with QC Controlled Substances documentation and accountability procedures.

Provides support and oversees the VWR Inventory Management Sandoz Wilson site Achievement: Galaxy Awardee for Going "Above and Beyond" (April 22. 2009)

Handled instrumental (HPLC and GC) and wet analysis of raw materials; investigations and deviation associated with raw material testing .

Facilitated the Residual Solvent Project (6/25/2008-12/15/2008), by coordinating with various departments to pull information and all requirements necessary to comply with USP <467> General Chapters.

As a Lead of the Control Center Project (5/09/2009 – Sept. 30, 2009), had worked with a consultant and various Sandoz department heads to set up the Sample Control Center . Project included the creation of all RM and FP worksheets used for testing, organization of sample flow processes in Quality Control, development of metrics and trending to track laboratory activities, training and development of staff to implement kitting that defines which lots and tests can be campaigned together for QC testing and use LIMS from sample receipt process to release.