QA Stability Specialist

Amneal

4d

About The Position

The Stability Coordinator II is responsible for implementing, leading, and managing the iStability software and entering data for all ANDA batches. The role also performs statistical evaluation of stability data as needed. Responsibilities include preparing and managing stability studies, protocols, and reports; maintaining iStability software and related SOPs; evaluating data for trends; and escalating adverse trends to management. The position trains subordinates in software use and identifies excess samples in storage that should be discarded.

Requirements

• Associate degree in Chemistry or a related science discipline.
• At least 5 years of experience managing a stability program with an associate degree, or at least 3 years with a bachelor's degree.
• Understanding of stability data in relation to specifications.
• Familiarity with current stability guidance from the Agency.
• Proficiency in Microsoft Office applications and software programs related to LIMS.
• Ability to understand and apply cGMP requirements.

Nice To Haves

• Bachelor's degree (BA/BS) in Chemistry or a related science discipline.

Responsibilities

• Create studies for each product and batch; enter, review, and approve sample data in the software and evaluate it periodically.
• Prepare, review, and approve stability protocols for all ANDA products.
• Manage and maintain iStability software updates and create and review related SOPs.
• Prepare, review, and obtain approval for stability reports.
• Evaluate data for trends, perform statistical evaluations as needed, and escalate adverse trends to management.
• Train subordinates in the use of iStability software.
• Identify extra samples in storage that need to be discarded.
• Perform regression analysis of stability data.
• Prepare justifications when required for extension of expiration dating.
• Perform other duties as assigned.

Benefits

• Short-term incentive opportunity, such as a bonus or performance-based award, within the first 12 months.
• Comprehensive, flexible benefits program for eligible positions.
• Health and insurance benefits.
• 401(k) matching contribution.
• Employee well-being programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree