QA Stability Specialist
About The Position
The QA Stability Specialist 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. The position prepares, reviews, and approves stability protocols and reports for ANDA products; manages iStability software updates and related SOPs; evaluates data for trends; and escalates adverse trends to management. It also trains subordinates in iStability software usage, identifies extra samples in storage that should be discarded, performs regression analysis, and prepares justifications when expiration dating extensions are required. Other duties may be assigned.
Requirements
- Associate degree in Chemistry or a related science discipline is required.
- 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 Agency stability guidance.
- Proficiency in MS Office applications and software programs related to LIMS.
- Understanding and ability to 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 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 to use iStability software.
- Identify extra samples in the storage area that need to be discarded.
- Perform regression analysis of stability data.
- Prepare justifications for extensions of expiration dating when required.
- Perform other duties as assigned.
Benefits
- Short-term incentive opportunity, such as a bonus or performance-based award, within the first 12 months.
- Health and insurance benefits.
- 401(k) matching contribution.
- Employee well-being programs.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
