Quality Management Assistant

The Quality Management Assistant supports and assists with maintaining quality systems and regulatory compliance within a pharmaceutical distribution center to ensure distribution activities comply with cGMP and regulatory requirements.

Essential Functions / Responsibilities:
- Assist with preparation and review of Batch Documents for distribution disposition (Certificate of Analysis, Certificate of Compliance, Serialization report, and Temperature/humidity data) to ensure completeness, accuracy, and compliance.
- Support the customer returns process per applicable SOP, ensuring returned product is evaluated, documented, and dispositioned in compliance with cGMP.
- Assist with inventory status to ensure products are classified and controlled in Hold, Quarantine, Released, and Morgue locations; maintain accurate system status and segregation.
- Support shipping studies per approved protocols to ensure product integrity and compliance with temperature and handling requirements.
- Assist with ad hoc sampling activities as requested by manufacturing/packaging/contract manufacturing sites; collect, document, and handle samples per SOPs and cGMP.
- Issue controlled forms and logbooks to stakeholder departments as requested, ensuring proper documentation, tracking, and compliance with document control.
- Support internal, customer, and regulatory audits via preparation, participation, and documentation review.

Qualifications:
- Education: High School or GED (Required)
- Experience: 2+ years in Pharmaceutical Distribution and/or Quality Assurance

Required Skills/Knowledge:
- Proficiency with Microsoft Office
- Ability to write and read in English
- Familiarity with FDA regulations for OTC and prescription drug products
- Working knowledge of cGMP
- Familiarity and ability to use office machines