Quality Management Assistant
Amneal Pharmaceuticals
August 25, 2026
On-site
Glasgow, KY
Operations
The Quality Management Assistant supports and assists with maintaining quality systems and regulatory compliance within a pharmaceutical distribution center, providing daily quality assistance to ensure distribution activities comply with cGMP and regulatory requirements.
Essential Functions:
- Assist with the preparation and review of Batch Documents for distribution disposition (Certificate of Analysis, Certificate of Compliance, Serialization report, and Temperature and humidity data).
- Support the customer returns process per applicable SOPs, ensuring returned product is evaluated, documented, and dispositioned in compliance with cGMP.
- Maintain accurate inventory status and segregation in Hold, Quarantine, Released, and Morgue locations.
- Support shipping studies per approved protocols to ensure product integrity and temperature/handling compliance.
- Assist with ad hoc sampling activities as requested by manufacturing/packaging/contract manufacturing sites, ensuring collection, documentation, and handling per SOPs and cGMP.
- Issue controlled forms and logbooks to stakeholder departments as requested, ensuring proper documentation, tracking, and document control.
Additional Responsibilities:
- Support internal, customer, and regulatory audits by assisting with preparation, participation, and documentation review.
- Perform other assigned duties supporting quality systems and regulatory compliance.
Qualifications:
- Education: High School or GED (Required)
- Experience: 2+ years in Pharmaceutical Distribution or Quality Assurance
- Skills/Knowledge: Proficient in Microsoft Office; able to write/read in English; familiarity with FDA regulations for OTC and prescription drug products; working knowledge of cGMP; ability to use office machines.
Essential Functions:
- Assist with the preparation and review of Batch Documents for distribution disposition (Certificate of Analysis, Certificate of Compliance, Serialization report, and Temperature and humidity data).
- Support the customer returns process per applicable SOPs, ensuring returned product is evaluated, documented, and dispositioned in compliance with cGMP.
- Maintain accurate inventory status and segregation in Hold, Quarantine, Released, and Morgue locations.
- Support shipping studies per approved protocols to ensure product integrity and temperature/handling compliance.
- Assist with ad hoc sampling activities as requested by manufacturing/packaging/contract manufacturing sites, ensuring collection, documentation, and handling per SOPs and cGMP.
- Issue controlled forms and logbooks to stakeholder departments as requested, ensuring proper documentation, tracking, and document control.
Additional Responsibilities:
- Support internal, customer, and regulatory audits by assisting with preparation, participation, and documentation review.
- Perform other assigned duties supporting quality systems and regulatory compliance.
Qualifications:
- Education: High School or GED (Required)
- Experience: 2+ years in Pharmaceutical Distribution or Quality Assurance
- Skills/Knowledge: Proficient in Microsoft Office; able to write/read in English; familiarity with FDA regulations for OTC and prescription drug products; working knowledge of cGMP; ability to use office machines.