Quality Assurance Associate I

Position Overview

An entry level quality assurance position with responsibilities including:

• assisting with the organization and implementation of training for employees
• assisting with SOP/Protocol drafting, editing and routing
• creation and completion of cGMP/GLP records and archival activities
• assisting QAU Management with internal and external facility audits as well as audit R&D, cGMP and GLP data as applicable
• assisting with the verification that the facility and records are in compliance with appropriate regulatory requirements – including US FDA Good Laboratory Practices (GLP) and US FDA current Good Manufacturing Practices (cGMP) – and providing back‑up support to all quality system functions as necessary
• additional projects as directed by QAU Management