Quality Management Assistant

RXinsider LTD.; Glasgow (KY); On-site; USD 42,000 - 54,000; Full time

Job summary

RXinsider LTD. seeks a Quality Management Assistant to help maintain quality systems and regulatory compliance within a pharmaceutical distribution center. You will support daily quality activities to ensure cGMP compliance and patient safety across distribution processes.

Responsibilities include assisting with batch document preparation, inventory status, returns disposition, and environmental monitoring, plus participation in audits and ongoing quality improvement efforts.

Qualifications

• High School or GED - Required.
• 2+ years in Pharmaceutical Distribution or Quality Assurance.
• Must be able to read and write in English and be computer literate.
• Familiar with FDA regulations and cGMP.

Responsibilities

• Assist with maintaining quality systems and regulatory compliance in the distribution center.
• Support batch document preparation and review (COA, Certificate of Compliance, serialization, temp/humidity data).
• Support inventory status, returns disposition, and hold/quarantine/released/morgue classifications in the system.
• Assist with shipping studies to ensure product integrity and compliant handling during distribution.
• Support ad hoc sampling per SOPs and cGMP requirements.
• Issue controlled forms and logs to stakeholders with proper documentation.
• Assist with internal, customer, and regulatory audits and documentation review.
• Perform other duties to support quality systems and regulatory compliance.

Skills

English reading/writing

Computer literacy (MS Office)

Regulatory knowledge (FDA regulations)

Education

High School Diploma or GED

Tools

Microsoft Office

Job description

Job Description

Description:

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.

Qualifications:

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.