What are the responsibilities and job description for the Quality Assurance Specialist position at Orion Group?
Location: North Chicago, IL
Contract Length: through EOY
Pay Rate: $26-28/hr
Description:
- 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
Education/Experience:
- High school degree is required. Bachelor’s degree is preferred
- 2-4 years in Quality Assurance, Process Support, Manufacturing, Distribution, Quality Control or similar area.
- Understand manufacturing/distribution process
- Product responsibility for compliance troubleshooting
Salary : $26 - $28
