Description:
Essential Functions:
- Perform investigations independently to assess aberrant events impacting product quality that could prevent product release. Performs interviews and schedule follow-up meetings in response to investigations.
- Perform gap assessments and root cause analysis evaluations to determine RISK level utilizing root cause analysis tools such as FMEA, wishbone and/or 5 Why tools.
- Directly supports the business through schedule/timeline adherence of NOI closures to allow for timely ANDA submissions, new product launches, and batch releases.
- Recommend quality process improvements to increase efficiencies and performance of systems, operations and personnel and prevent reoccurrence of incident or event.
- Writes investigation reports in a clear and concise manner to withstand regulatory scrutiny, with sufficient detail to support decisions drawn and actions taken to resolve an event.
- Identify and resolve objectionable GMP issues which may impact product quality and escalate the issues to supervisor in a timely manner.
- Ensure all work is performed and documented in accordance with existing Company policies and procedures, as well as GMP and health and safety requirements in the markets where product is sold.
Additional Responsibilities:
- As required, adhere to gowning and safety protocols by wearing appropriate personal protective equipment (PPE) to maintain product quality, environmental compliance, and personal safety.
- Applies technical expertise and professional judgment to determine CAPA effectiveness, ensuring deficiencies are identified, communicated, and addressed through appropriate management channels.
Education:
- Bachelors Degree (BA/BS) Science or Engineering, Quality Management or related field - Required
Experience:
- 3 years or more in Working in the Pharmaceutical or Medical Device industry
- 3 years of Experience working in GMP/FDA regulated environment
- 3 years on Hands on experience in a production
Specialized Knowledge:
- Use of Risk Assessment tools
The base salary for this position ranges from $75,000 to $95,000 per year. Amneal ranges reflect the Company’s good faith estimate of base salary that 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, 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 helps you enjoy your career alongside life’s many other commitments and opportunities.
Skills Required
- Bachelor's degree in Science, Engineering, Quality Management or related field
- 3+ years working in the Pharmaceutical or Medical Device industry
- 3+ years experience in a GMP/FDA regulated environment
- 3+ years hands-on production experience
- Experience performing investigations, interviews, and writing investigation reports
- Experience with root cause analysis and risk assessment tools (FMEA, fishbone, 5 Whys)
- Knowledge of CAPA processes and ability to assess CAPA effectiveness
- Knowledge of GMP and health and safety requirements for regulated products
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.
