The Operations-Compliance Specialist utilizes deductive reasoning, interviewing skills and technical knowledge to perform investigations to find causes of aberrant events and circumstances impacting the products. The role work independently in the resolution of quality related issues by gathering relevant information, determining the accurate cause and defining appropriate corrective/preventive actions to prevent recurrence.
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.
- Supports the business through schedule/timeline adherence of investigations closures to allow for timely new product launches, and batch releases.
- Perform gap assessments and root cause analysis evaluations to determine the exact cause of incident
- Identify and resolve objectionable cGMP issues which may impact product quality and escalate the issues to supervisor in a timely manner.
- Writes investigation reports in a clear and concise manner to withstand regulatory requirement.
- Prepares weekly/monthly status reports for departmental updates/meetings.
Additional Responsibilities:
- Ensure all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP and health and safety requirements.
- Bachelors Degree (BA/BS) Chemistry, Pharmaceuticals, Biology or a Engineering - Required
- 2 years or more in Preferable working in cGMP regulated pharmaceutical particularly in operations
- Working knowledge of pharmaceutical manufacturing, packaging and laboratory processes.
- Working knowledge of cGMPs as defined in the regulatory guidances.
- Working knowledge of Operations related Investigations.
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.
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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.
