The Quality Management Assistant supports and assists with maintaining quality systems and regulatory compliance within a pharmaceutical distribution center. This role provides daily quality assistance to ensure distribution activities comply with cGMP and regulatory requirements. Responsibilities include supporting inventory control, customer returns, environmental monitoring, pest control programs, and overall compliance, helping to ensure product quality, integrity, and patient safety throughout the distribution process.
Essential Functions:
- Assists with the preparation and review of Batch Documents for distribution disposition- Certificate of Analysis, Certificate of Compliance, Serialization report and Temperature and humidity data to ensure completeness, accuracy, and compliance with approved specifications.
- Support the customer returns process in accordance with the applicable Standard Operating Procedure (SOP), ensuring returned product is evaluated, documented, and dispositioned in compliance with cGMP requirement
- Assist with inventory status within the distribution center to ensure products are appropriately classified and controlled in Hold, Quarantine, Released, and Morgue locations, maintaining accurate system status and segregation at all times
- Support shipping studies in accordance with approved protocols and procedures to ensure product integrity and compliance with temperature and handling requirements during distribution.
- Assist with performing ad hoc sampling activities as requested by Amneal manufacturing, packaging, and contract manufacturing sites, ensuring samples are collected, documented, and handled in accordance with established SOPs and cGMP requirements.
- Issue controlled forms and logbooks to stakeholder departments as requested, ensuring proper documentation, tracking, and compliance with established SOPs and document control requirements.
Additional Responsibilities:
- Support internal, customer, and regulatory audits by assisting with preparation, participation and documentation review.
- Perform other duties and responsibilities as required or assigned to support quality systems, regulatory compliance, and business needs.
Education:
- High School or GED - Required
Experience:
- 2 years or more in Pharmaceutical Distribution, Quality Assurance
Specialized Knowledge:
- Must be computer literate in a Microsoft Office.
- Must be able to write and read in English.
- Must possess familiarity with Food and Drug Administration (FDA) regulations, as it relates to OTC and Prescription drug products.
- Working knowledge of Current Good Manufacturing Practices (cGMP) is required.
- Must possess high degree of familiarity with and ability to use office machines.
Skills Required
- High School diploma or GED
- 2 years or more in Pharmaceutical Distribution or Quality Assurance
- Working knowledge of Current Good Manufacturing Practices (cGMP)
- Familiarity with FDA regulations for OTC and prescription drug products
- Computer literate in Microsoft Office
- Ability to read and write English
- Familiarity with and ability to use office machines
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.
