QA Compliance Specialist (Contract Initially)

Pay: $30–$38 per hour
Location: North Chicago, IL

Overview

The QA Compliance Specialist ensures compliance with FDA current Good Manufacturing Practices (cGMP), current Good Distribution Practices (cGDP), and corporate policies and procedures. This position provides guidance on operational processes, procedural issues, and the accuracy and adequacy of quality documentation.

The specialist will assess operational and distribution outages, temperature excursions, and deviations to determine compliance with established specifications and procedures. This role also supports product acceptance, compliance troubleshooting, quality investigations, audits, and cross-functional problem-solving activities.

Key Responsibilities

• Serve as the site CAPA coordinator and administrator for shipment temperature management.
• Act as the primary quality interface for FDA, supplier, customer, and corporate audits and inspections.
• Manage projects supporting quality and compliance initiatives.
• Maintain and manage the validation document library.
• Conduct investigations involving product quality complaints, product diversion, and distribution-related concerns.
• Manage the warehouse temperature monitoring program.
• Serve as the primary Quality Assurance contact for new product introduction (NPI) launches.
• Execute the placement and removal of QA holds within the warehouse management system.
• Manage and post supplier audit information in the appropriate quality database.
• Manage market authorization activities and Master Data Management processes.
• Analyze complex technical data related to product acceptance and compliance.
• Collaborate with R&D, Process Development, Manufacturing, Operations, Distribution, and Engineering to resolve product and process issues.

• Bachelor’s degree preferred.
• At least four years of experience in Quality Assurance, process support, engineering, manufacturing, operations, distribution, or a related area.
• Knowledge of cGMP, cGDP, manufacturing, and distribution processes.
• Experience reviewing deviations, investigating problems, and evaluating compliance concerns.
• Experience supporting product compliance and troubleshooting activities.
• Experience serving as a quality representative during audits or inspections.
• Ability to analyze complex technical data and make sound product acceptance decisions.
• Strong problem-solving skills and creativity in resolving quality and operational issues.
• Effective negotiation and relationship-management skills when working with manufacturing and distribution stakeholders.
• Ability to collaborate across R&D, Process Development, Manufacturing, Operations, Distribution, and Engineering teams.