What are the responsibilities and job description for the Quality Assurance Compliance Specialist position at Systems Ally?
Hiring: Quality Assurance Compliance Specialist
Location: North Chicago, IL
No C2C
Position Overview
We are seeking a Quality Assurance Compliance Specialist to support compliance with FDA current Good Manufacturing Practices (cGMP) and Good Distribution Practices (cGDP) regulations.
The ideal candidate will provide quality guidance across operational processes, documentation, distribution activities, investigations, audits, and quality improvement initiatives.
Key Responsibilities
• Serve as Site CAPA Coordinator/Administrator for shipment temperature management
• Support FDA, supplier, customer, and corporate audits/inspections
• Lead project management activities for Quality Initiatives
• Manage the Validation Library and related documentation
• Conduct product quality, diversion, and distribution complaint investigations
• Manage the warehouse temperature monitoring program
• Serve as the Quality Point Person for New Product Introduction (NPI) launches
• Execute placement and removal of QA Holds in the Warehouse Management System
• Manage and post supplier audit data in the appropriate database
• Support Market Authorization and Master Data Management processes
Required / Preferred Qualifications
• Bachelor’s degree preferred
• 4 years of experience in Quality Assurance, Process Support, Engineering, Manufacturing/Operations, Distribution, or a related field
• Strong understanding of manufacturing and distribution processes
• Experience with problem-solving and compliance troubleshooting
• Experience supporting audits and regulatory inspections
• Strong analytical skills with the ability to evaluate complex technical/product data
• Ability to support product and process problem-solving
• Strong communication and negotiation skills with Manufacturing and Distribution stakeholders
• Creative and effective approach to resolving quality and compliance issues
• Ability to collaborate cross-functionally with R&D, Process Development, Manufacturing/Operations, and Engineering
Core Skills
Quality Assurance | cGMP | cGDP | FDA Compliance | CAPA | Audits | Investigations | Validation | Quality Systems | NPI | Temperature Monitoring | QA Holds | Supplier Audits | Master Data Management | Pharmaceutical Quality