QA Stability Specialist

The QA Stability Specialist is responsible for implementing, leading and managing the iStability/LIMS software; entering data for all ANDA batches; and performing statistical evaluation of the data as required.

Essential Functions:
- Create studies for each product and batch; enter, review, and approve data in the software for each sample; evaluate results over time.
- Prepare, review, and approve stability protocols for all ANDA products; manage/maintain iStability/LIMS updates; create/review related SOPs.
- Prepare and review stability reports; obtain approvals; evaluate trends; perform statistical evaluation as required; escalate adverse trends to management.
- Train subordinates on iStability/LIMS software usage.
- Identify extra samples in storage area for discard.

Additional Responsibilities:
- Perform regression analysis of stability data; prepare justifications when required for extension of expiration dating.

Qualifications:
Education:
- Associate Degree in Chemistry or related science discipline (Required)
- Bachelor’s Degree (BA/BS) in Chemistry or related science discipline (Preferred)

Experience:
- 5+ years in an Associate Degree role: 5+ years managing a stability program
- 3+ years in a Bachelor’s role: 3+ years managing a stability program

Specialized Knowledge/Skills:
- Understanding of stability data vs. specification; familiarity with current agency stability guidance
- Proficient in MS Office; experience with LIMS-related software
- Ability to understand and apply cGMP requirements
- Base salary range: $60,000–$85,000/year
- Short-term incentive opportunity (bonus/performance-based award) within first 12 months