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Über
The QA Stability Specialist is responsible for implementing, leading and managing the iStability/LIMS 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/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. Other duties as assigned. Qualifications
Education: Associate Degree Chemistry or related science discipline - Required Bachelors 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. Required Skills
Calibration Data-Driven Decision Making Facility Inspection First Article Inspections Good Manufacturing Practices Investigation Laboratory Information Management Systems Quality Management Systems Troubleshooting (Problem Solving) United States Pharmacopeia (USP) Compliance Visual Inspections Job Info
Job Identification 8261 Job Category Quality Assurance Locations 19 Readington Road, Branchburg, NJ, 08876, US Job Schedule Full time
Sprachkenntnisse
- English
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