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QA Stability Specialist
- Branchburg Township, NJ, United States
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The original listing is kept below for reference.
Job details
- Posting language
- English
- Posted
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Description:
The Stability Coordinator II is responsible for implementing, leading and managing the iStability 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 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 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.