QA Assistant — Pharma Distribution & Compliance

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

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.