Job Description

The QA Stability Specialist is responsible for implementing, leading and managing the iStability/LIMS software and entering the data in the software for all the ANDA batches and to perform the statistical evaluation of the data as and when required.

Essential Functions:

• Create the studies for each product and each batch, enter the data and review and approve them in the software for each sample and evaluate them time to time.
• Prepare, review and approve the stability protocols for all ANDA products. Manage and maintain the updates of the iStability/LIMS software and create and review the related SOP.
• Prepare the stability reports, review the reports, and get them approved. Evaluate the data for trends and perform the statistical evaluation as and when required and escalate to management for any adverse trends.
• Train the subordinates for iStability/LIMS software usage.
• Identify extra samples in the storage area that would need to be discarded.

Additional Responsibilities:

• Perform regression analysis of stability data. Prepare justifications, when required for extension of expiration dating. Other duties as assigned.

Education:

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

Experience:

• 5 years or more in AD- 5 years experience managing a stability program
• 3 years or more in BA/BS- 3 years experience managing a stability program

Specialized Knowledge:

• Must possess understanding of stability data with respect to specification. Must be familiar with current stability guidance from the Agency. Proficient in MS office applications, software programs related to LIMS. Must understand and apply cGMP requirements.

The base salary for this position ranges from $60,000 to $85,000 per year. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, with this position within the first 12 months. Amneal ranges reflect the Company’s good faith estimate of what 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, experience, 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 help you enjoy your career alongside life’s many other commitments and opportunities.