QA Specialist
 Spectraforce Technologies | |
 United States, Illinois, North Chicago | |
 Mar 27, 2025 | |
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Job Title: QA Specialist
Location: North Chicago, IL 60085 Duration: 10 Months 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. 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 Required Skills: 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. Reviewing problem solving situation Understand manufacturing / distribution process Product responsibility for compliance troubleshooting Audit interface Creativity in resolving issues Negotiation skills with Mfg. / Distribution customers | |