Quality Assurance Associate I

Position Overview

An entry level quality assurance position. Responsibilities include, but are not limited to: assisting with the organization and implementation of training for employees; assisting with SOP/Protocol drafting/editing/routing; creation and completion of cGMP/GLP records and archival activities; and assisting QAU Management with internal and external facility audits as well as audit R&D, cGMP and GLP data as applicable. An employee in this position will be expected, when fully trained, to assist 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 to provide back-up support to all quality system functions as necessary. This position may also have additional projects as directed by QAU Management.

Critical Performance Areas