I focus on ensuring adherence to GLP and regulatory standards. I have developed new job descriptions and classifications for the QC laboratory team and actively participate in the selection of highly qualified candidates. Implemented robust systems and procedures, to record, monitor, and maintain quality results, ensuring the QC laboratory's performance aligns with cGMP, GLP, and company protocols.

Overseeing both operational and technical aspects of the QC lab, managing personnel, and maintaining equipment. I execute laboratory testing of cGMP samples, review and compile test data, and conduct thorough analyses to ensure accuracy and compliance. Additionally, I provide technical expertise for manufacturing deviations, collaborating closely with manufacturing and quality assurance teams. I am responsible for authoring, reviewing, and approving critical documentation such as technical reports, SOPs, protocols, and trend analyses to support ongoing process control activities. I proactively identify and resolve gaps while offering technical support and troubleshooting for equipment, procuring raw material manufacturer agreements, and data analysis. I also provide training and guidance to junior analysts and contribute to continuous process improvement initiatives, demonstrating my commitment to maintaining high standards and advancing organizational goals.

I assisted in various crucial aspects of process development and validation, including process qualification and test method validation. This involved contributing to the establishment and execution of these processes to ensure compliance and efficiency. Additionally, I played a key role in supporting the Quality Management System (QMS) to uphold ISO 13485 certification standards, maintaining rigorous adherence to regulatory requirements. I also provided essential support to Manufacturing by ensuring the upkeep of a Class 7 Cleanroom environment, adhering to ISO 14644-1 standards. My responsibilities included the preparation of technical and manufacturing documents and reports, which facilitated smooth operational processes. I operated and maintained equipment according to defined schedules and protocols, ensuring thorough quality control checks, preventive maintenance, and calibration procedures were consistently carried out. I demonstrated proficiency in recognizing critical, abnormal, and unacceptable test results, adhering to established protocols for resolution. Furthermore, I conducted training sessions for new hires on test methods and procedures, contributing to the development of a skilled and knowledgeable team. Additionally, I assisted in Good Manufacturing Practice (GMP) product manufacturing efforts, focusing on maintaining high-quality standards throughout documentation and production processes.

Provided rapid covid testing at various film production sites throughout the Pittsburgh area. Completed all tests in a mobile lab while uploading results to Kameo software in real time.

A one year rotational program requiring traveling to and working in multiple research laboratories throughout the DMV area fulfilling a variety of positions. The Corporate Response Team is responsible for providing continuing service to Charles River Laboratories clients throughout the United States. This program offers experience in multiple research labs for a glimpse of current projects. Such jobs include monitoring mice and rat colonies by performing daily animal health observations and husbandry duties. Other job tasks vary from documentation and record keeping to practicing sterile technique while working with laboratory animals.