Job Summary

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.

Qualifications

Education

• Associate Degree in Chemistry or related science discipline - Required
• Bachelors Degree (BA/BS) in Chemistry or related science discipline - Preferred

Work Experience

• AD with 3 years handling a stability program - Required
• BA/BS with 1 year handling a stability program - Preferred

Skills and Abilities

• Must be detail-oriented, meticulous, precise and consistent in laboratory data entries and stability sample information in the stability database. - Advanced
• Must be flexible to adapt to changes in assignments. - Advanced
• Must work well within a team. - Advanced
• Must have the ability to handle a stability database and effectively communicate any problems or issues. - Advanced

Specialized Knowledge

• Must possess understanding of stability data with respect to specification.
• Must be familiar with current stability guidance from the Agency.
• Must be precise and consistent in day to day activities.
• Must be proficient in Microsoft Software (MS) office applications, and software programs related to Laboratory Information Management Systems (LIMS).

The annual base salary for this position ranges from $ 21.00 to $ 25.00. Amneal ranges reflect the Company’s good faith estimate of base salary that Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that helps you enjoy your career alongside life’s many other commitments and opportunities.