New · posted Oct 31
Amneal Pharmaceuticals · Pharmaceuticals
QA Stability Specialist
- Branchburg Township, NJ
- On-site
- Full-time
- Associate & Specialist
The role
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.
What you need
Education
- Associate degree Chemistry or related science discipline - Required
- Bachelor's 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.
The salary range for this position ranges from $60,000 per year to $75,000 per year. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, with this position within the first 12 months. Amneal ranges reflect the Company’s good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills.
At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life’s many other commitments and opportunities.
What you'll do
- 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.
Perform regression analysis of stability data. Prepare justifications, when required for extension of expiration dating. Other duties as assigned.
Pay and benefits
$60,000 a year
Employer providedShort-term incentive/bonus opportunity
Health and insurance benefits
401(k) matching contribution
Well-being programs
Where you'll work
Branchburg Township, NJOn-siteOpen in Maps (opens in a new tab)
More jobs in Branchburg Township, NJJob intelligence
The context around this role
Live data · November 1, 2026
Salary intelligence
How the pay compares
This role's midpoint is 4% below the US median for Quality Control roles at this level.
This roleEmployer provided
Associate & Specialist roles in New Jersey5 roles publishing pay
Associate & Specialist roles in the US133 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $60,000 | — | $60,000 |
| New Jersey (middle half) | $59,000 | $60,000 | $64,500 |
| All US (middle half) | $49,500 | $62,500 | $79,500 |
This role: Amneal Pharmaceuticals's own published range. Comparisons: the base pay employers published on open Quality Control roles at the same level on Regulatory Jobs, November 1, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Control
The general path across 353 open Quality Control roles on Regulatory Jobs, with the titles they carry most. Not Amneal's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 14 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Lab testing and methods10
- Data and digital systems5
- Regulatory submissions3
- Documentation and SOPs2
- GMP and compliance1
- Clinical trial conduct1
- Collaboration and leadership1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
Amneal on Regulatory Jobs
- 17
- Open roles
- 12
- Distinct roles
- 3
- Locations
By discipline
- Quality17 100%
By level
- Senior & Principal7 41%
- Associate & Specialist7 41%
- Manager2 12%
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QA Stability Specialist at Amneal
Open until filled. $60K a year, employer provided.