Specialist

Job Description

Purpose

Assure compliance with FDA current Good manufacturing Practices (cGMP) and Good Distribution Practices (cGDP) regulations. Assure compliance with Corporate policies/procedures and provide guidance on operational processes, procedural issues and documentation content and adequacy.

Assess operations/distribution outages and deviations to determine compliance with specifications and procedures.

Responsibilities

Approve/initiate changes to Distribution Operations and QA procedures, facility and equipment

Audit Interface- FDA, supplier, customer inspection, corporate

Conduct product quality, diversion and distribution complaint investigations

Manage warehouse temperature monitoring program

Initiate exceptions reports in the appropriate database

Perform inbound quality inspections and usage decision

Execute domestic and international sales/recall reports

Execute placement and removal of QA Holds in warehouse management system

Manage/Post supplier audit data in appropriate database

Manage market authorization process and Material Data Management