Title: Sr. QA Specialist
Location: Lake Bluff, Chicago
Type: Direct hire, full time, permanent
Schedule: Hybrid
Sponsorship: No
Responsibilities
- In this role you will manage and maintain various regulatory compliance programs, as well as providing specific and advanced support as needed to other quality assurance functions and customers
- Manages the site Customer Complaint Investigation Program activities
- Maintains effective communication with Service groups for site's product complaint investigations
- Includes review of complaint cases at earliest stage to assess Technical Service performance
- Labeling Regulatory Compliance, including reviewing product labeling to assure compliance with product claims and supporting the labeling control process
- Product Recall / Field Action Activities; coordinate activities as required
Qualifications:
- Bachelor's Degree in Chemistry, Biology, Life Sciences, or related technical field
- Working knowledge and experience with FDA cGMPs/QSR, and ISO Quality system requirements
- Demonstrated understanding of lab practices