Angela Epps Email & Phone Number

Leads the stability programs of projects from research to full development phase (product launches), including exploratory or feasibility studies, new materials, existing product or packaging changes.Oversees the design, implementation and execution of stability protocols in compliance with FDA, ICH and ISO stability requirements in a cGMP industry .Advances departmental endeavors by representing the stability program on cross-functional project teams including Regulatory Affairs and Quality to determine stability variables, recommend test methodologies and devise project stability strategies.Facilitates success of direct reports by serving as a coach, mentor and supervisor to assist in optimal performance outcome and career growth. Authors and investigates reports to determine the root causes for nonconformities / deviations / out of specification events.Applied technical knowledge to support incoming complaints on commercial products.

Successfully developed stability strategy for compliancy for Phase I and Phase II clinical studies. Initiated first Zone III and Zone IV shelf life studies for two lens care products with analysis of lens care and lenses using wet chemistry methods and stability protocols.Ensured quality with OOS documentation for product that did not meet specification.Consistently maintained calibration of instrumentation and standards used for stability and shelf life determinations.

Demonstrated success in an inter-departmental collaborative environment.Fully revised stability-related SOP's to meet current regulatory standards. Assisted in design of stability data management system for stability studies, calculation of product pulls, and calculations of the metrology changes from baseline.

Managed all stability data for the shelf life reports for the implementation of new products. Coordinated stability lab move from Amwiler site to current John’s Creek, GA location.Developed stability testing criteria for contact lenses for major conversion from flat pack foil packaging to tortoise packaging.