Specialist, Distribution Quality Assurance

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