Description:
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.
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.
The base salary for this position ranges from $60,000 to $85,000 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.
Skills Required
- Associate Degree in Chemistry or related science discipline
- Bachelor's Degree (BA/BS) in Chemistry or related science discipline
- 5 years stability program management experience (with Associate Degree) or 3 years (with Bachelor's Degree)
- Experience implementing and managing iStability and other LIMS software
- Proficiency in Microsoft Office applications
- Familiarity with current regulatory stability guidance and ability to apply cGMP requirements
- Ability to perform statistical evaluation and regression analysis of stability data
- Experience preparing, reviewing, and approving stability protocols and reports
- Ability to train and supervise subordinate staff on iStability/LIMS usage
Amneal Pharmaceuticals Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Amneal Pharmaceuticals and has not been reviewed or approved by Amneal Pharmaceuticals.
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Healthcare Strength — Medical coverage is presented as comprehensive with day-one eligibility for many U.S. roles, supported by wellness resources and transparency around plan information.
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Affordable Benefits — Employer contributions toward health coverage are described as generous, including periods where cost increases were absorbed and future employee contributions kept below broader trends.
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Retirement Support — A 401(k) plan with a company match and strong participation is positioned as a core element of the Total Rewards package.
Amneal Pharmaceuticals Insights
What We Do
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) is guided by a simple belief: essential medicines should be accessible to everyone. What began as a promise to deliver high-quality, affordable medicines has evolved into a diversified portfolio spanning complex generics and injectables, biosimilars, and specialty medicines, including more than 290 products, with scale and capabilities that help reach patients across the healthcare system while combining world-class precision with a deep sense of personal responsibility for every dose we deliver. Content is for informational purposes only and 3rd party content does not reflect Amneal’s opinions. Amneal has the right to remove comments that violate another’s copyright or intellectual property, mention an Amneal product, use profanity or are defamatory, promote and solicit for third-party sites, initiatives, or products, or are factually inaccurate or misleading or spam. Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or [email protected]. If you are currently experiencing a life-threatening event, please immediately contact 911.
