Quality Management Assistant

Responsibilities

• Supports the preparation and review of Batch Documents for distribution disposition including Certificate of Analysis, Certificate of Compliance, Serialization report and Temperature and humidity data.
• Supports 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 requirements.
• Affords assistance 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.
• Assists with performing shipping studies in accordance with approved protocols and procedures to ensure product integrity and compliance with temperature and handling requirements during distribution.
• Assists 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.
• Issues controlled forms and logbooks to stakeholder departments as requested, ensuring proper documentation, tracking, and compliance with established SOPs and document control requirements.

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, write and read in English, possess familiarity with FDA regulations, work knowledge of cGMP, and high degree of familiarity with and ability to use office machines.