Description:

The Stability Coordinator I will handle the stability program for all assign products.

Essential Functions:

Ensure the accurate execution of the stability program for all products; which includes ensuring the samples are pulled in a timely manner, properly distributing samples, and maintain compliant storage conditions. Monitor stability storage conditions, ensure appropriate temperatures and humidity, prepare reports of trends, escalate issues as needed. Prepare and manage stability summary and regression reports. Ensure timely submission of reports to Quality Assurance (QA) and Regulatory Affairs (RA). Inform Management for significant change and/or trend observed in the stability report. Review and prepare stability protocols, initiate change control and stability in the system.

Additional Responsibilities:

Analytical Research and Development (AR & D) will handle the Abbreviated New Drug Application (ANDA) products Quality Control (QC) will handle the commercial products Other duties as assigned.