• Conduct Environmental Monitoring sampling of microbial non-viable per ISO 14644-1 method, viable per 1094-SDY method, and surface sampling within the aseptic manufacturing facilities to assure the environmental conditions are compliant with regulatory requirements. • Aseptically qualified for sterile process of injectable medical devices in Grade A. • Adherence to all FDA pharmaceutical regulations, ISO standards, and cGMP.• Good aseptic technique and excellent documentation skills to assure correct processing of samples. • Enumeration and documentation of viable and surface sampling, and liquid media. Assess the limits compared to the results to determine if an excursion within the environment has occurred. • Performed membrane filtration for WFI, USP, Potable, and swab bioburden samples in a Biological Safety Cabinet. • Familiar with WinKQCL program and Turbidimetric method• Participated and involved in media challenges • Coordinate with metrology to ensure equipment is calibrated and operating per departmental SOP's.• Provide leadership, development, and mentoring during training new employees.• Write, review, and revised Standard Operating Procedures, departmental forms, and work instructions for cGMP manufacturing of commercial product. • Initiate Deviations, Laboratory Investigations, and PR Reports• Implement CAPA’s and conduct troubleshooting and continuous improvement activities. • Facilitate communication of operational information to management, non-management, and support groups to ensure production deadlines are met.• Excellent attention to detail and ability to work in a fast paced environment with minimal supervision• Participated in external international audits and internal safety audits to answer compliance and process questions.• Emergency Response Team member, participating in spill control, handling of hazardous materials and first aid.

Test consumer products, raw materials, foods, and waters to ensure FDA Regulation by performing composites, dilutions, and neutralization, following Good Manufacturing Practices and Quality Assurance. Familiar with aseptic technique, pipetting, filtering, and Vidas testing.