QA Stability Specialist

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.

Qualifications

• Education: Associate Degree Chemistry or related science discipline - Required Bachelor's 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

Pay

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.