The QA Stability Specialist is responsible for implementing, leading and managing the iStability/LIMS software, entering data for all ANDA batches, and performing statistical evaluations as required. Essential Functions Create studies for each product and batch, enter data, review and approve them in the software, and evaluate them periodically. Prepare, review, and approve stability protocols for all ANDA products; manage and maintain the iStability/LIMS software updates; create and review related SOPs. Prepare stability reports, review and obtain approval; evaluate data for trends, perform statistical analysis as needed, and report adverse trends to management. Train subordinates on iStability/LIMS software usage. Identify extra samples in storage that should be discarded. Additional Responsibilities Perform regression analysis of stability data and prepare justifications for extensions of expiration dating; undertake other duties as assigned. Qualifications Education Associate Degree in Chemistry or related science discipline – required. Bachelor’s Degree in Chemistry or related science discipline – preferred. Experience 5 years or more in AD – managing a stability program. 3 years or more in BA/BS – managing a stability program. Specialized Knowledge Understanding of stability data relative to specifications and familiarity with current stability guidance from the Agency. Proficiency in MS Office, LIMS-related software, and application of cGMP requirements. Compensation Base salary ranges from $60,000 to $85,000 per year. Amneal offers a short‑term incentive opportunity, such as a bonus or performance‑based award, within the first 12 months. Compensation will ultimately be determined by qualifications, experience, geographic location and other relevant factors. Benefits The Total Rewards commitment includes a comprehensive, flexible and competitive benefits program for eligible positions, providing health and insurance benefits above market, a 401(k) matching contribution, and employee well‑being programs. #J-18808-Ljbffr
QA Stability Specialist • Branchburg Twp, NJ, United States
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