FDA RESUME - Unknown Company

Stefanie Cook serves as the Continuous Quality Improvement (CQI) Director at Alizée Pathology, a role she has held since September 2014. In this capacity, she is responsible for overseeing quality, compliance, training, safety, and continuous improvement systems within the company. Her role involves collaborating with the General Manager, Operations Director, and Office Manager to ensure that all facilities, personnel, methods, practices, records, and controls adhere to applicable good laboratory practices.

During her tenure, Stefanie has achieved significant milestones, including hosting an FDA Good Laboratory Practice (GLP) Bioresearch Monitoring routine surveillance inspection that resulted in no findings. The inspector commended Alizée's quality systems as exceeding expectations. Additionally, Stefanie has been instrumental in reorganizing the company's structure, contributing to a 10% increase in profit margin and enhanced owner satisfaction.

Stefanie's responsibilities include supervising and training a team of ten, leading quality system implementation, analyzing quality metrics, and advising on risk management. She ensures vendor evaluations are thorough and oversees the training system's adequacy. As the Safety Officer, she leads the Safety Team to maintain compliance with safety regulations.

Her achievements also include renovating the company safety program, implementing new pathology data software, and devising methods to track and analyze quality metrics. Stefanie's leadership in quality assurance has positioned Alizée Pathology as a model of compliance and continuous improvement in the industry.