Overview
Schedule
Full-time
Career level
Senior-level
Remote
On-site
Benefits
Career Development
Job Description
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.
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FAQs About QA Stability Specialist Jobs at Amneal Pharmaceuticals, Inc.
What is the work location for this position at Amneal Pharmaceuticals, Inc.?
This job at Amneal Pharmaceuticals, Inc. is located in Branchburg Township, NJ, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Amneal Pharmaceuticals, Inc.?
Employer has not shared pay details for this role.
What employment applies to this position at Amneal Pharmaceuticals, Inc.?
Amneal Pharmaceuticals, Inc. lists this role as a Full-time position.
What experience level is required for this role at Amneal Pharmaceuticals, Inc.?
Amneal Pharmaceuticals, Inc. is looking for a candidate with "Senior-level" experience level.
What benefits are offered by Amneal Pharmaceuticals, Inc. for this role?
Amneal Pharmaceuticals, Inc. offers Career Development for this position. Actual benefits may vary depending on the employer's policies and employment terms.
What is the process to apply for this position at Amneal Pharmaceuticals, Inc.?
You can apply for this role at Amneal Pharmaceuticals, Inc. either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.