Analyst/Inspector, Quality Operations
Analyst Accomplishments:-Provided analytical support to ensure that raw materials, in-process production samples and finished product test results were within current quality specifications-Utilized extensive instrumental techniques in daily laboratory activities to support the ultimate release of product-Performed calibration of laboratory instruments to maintain the instruments and ensure compliance with USP/SOP requirements-Managed laboratory supplies and chemical reagents inventory for entire deparmental use ensuring sfficient and cost effective laboratory operations-Wrote and reviewed laboratory standard operating procedures to maintain cGMP requirements and document accuracy-Utilized Laboratory Information Management System (LIMS) software for data calculation, entry and retrieval-Utilized DATA3 and SAP software for material disposition and material release-Assisted in investigation and documentation review of laboratory non-conformances-Disposed of laboratory hazardous waste and chemicals in compliance with current EPA/DEP requirementsInspector Accomplishments:-Provided oversight for sampling activities. This involved training and supervision of Warehouse Staff in accordance with cGMP guidelines-Inspected all incoming raw materials, packaging and labeling components to ensure adherence to current SOP and cGMP requirements-Inspected all factory intermediates and finished goods for proper labeling, weight accuracy and cGMP compliance in accordance with current requirements-Inspected outgoing domestic and international shipments to ensure current labeling procedures were followed-Wrote and reviewed Stansard Operating Procedures to reflect new SAP business practices and ensure cGMP compliance
