Tracy Beniger

Stability Program Leader @Kleen Test Products Corporation

Port Washington, WI, US

Oversee stability testing program for OTC, drug, and cosmetic products to maintain compliance with FDA, cGMP, and ICH guidelines to verify products meet quality and performance standards through expiration.• Analyze stability results to understand the impacts of program activities and improve the effectiveness of tools and methods used to identify sources of instability in projects.• Manage sample collection, testing, and statistical data analysis to validate product shelf life.• Generate stability reports and present these to customers and regulatory stakeholders for review, approval, and audit.• Track long-term trends and generate stability data to identify risks, inform expiration, and maintain product quality.• Translate complex technical results into actionable insights to guide product development and quality assurance strategies.• Communicate stability data and product registrations with customers and vendors.• Serve as a Safety Committee Member and a First Responder.• Monitor and maintain onsite stability chambers in alignment with regulatory standards and SOPs.• Track and analyze long-term and accelerated stability data, identifying trends impacting product performance and dating expiration.• Provide technical support during regulatory audits and customer inspections.• Perform extensive data tracking and reporting on product stability.

Martin's College of Cosmetology

Barbering and Cosmetology, Cosmetology/Cosmetologist

Lakeland University

Bachelor's degree, Management Information Systems (Data Science)

Plymouth High

High School Diploma, General Studies