Quality Assurance Compliance Specialist

Quality Assurance Compliance Specialist II

Pay Range: $30/hr to $35/hr

Location: North Chicago, IL 60064

Work Type: Onsite

Contract Duration: 12 Months Possible Extension

Job Summary:

We are seeking an experienced Quality Assurance Compliance Specialist II to support quality and compliance activities within a large enterprise environment. This role is responsible for ensuring compliance with regulatory requirements, quality standards, and internal procedures across manufacturing and distribution operations. The ideal candidate will collaborate with cross functional teams to investigate quality issues, support audits, manage compliance programs, and drive continuous process improvements. This position requires strong analytical skills, regulatory knowledge, and experience working in regulated environments.

Key Responsibilities:

• Coordinate CAPA activities related to shipment temperature management and ensure timely resolution of compliance issues.
• Support regulatory inspections, supplier audits, customer audits, and internal quality audits while serving as a primary quality contact.
• Lead and support quality improvement initiatives through effective project management.
• Maintain and manage the validation document library to ensure compliance with quality standards.
• Conduct investigations related to product quality issues, distribution complaints, and diversion events while documenting findings and corrective actions.
• Manage warehouse temperature monitoring activities to ensure product integrity.
• Support new product introduction activities by serving as the quality representative.
• Execute quality hold placement and removal activities within the warehouse management system.
• Maintain supplier audit records and quality documentation within approved databases.
• Support market authorization activities and master data management processes.

Required Qualifications:

• Bachelor degree preferred with equivalent relevant experience considered.
• Minimum 4 years of experience in Quality Assurance, Process Support, Engineering, Manufacturing, Operations, Distribution, or a related field.
• Experience supporting FDA current Good Manufacturing Practices and Good Distribution Practices compliance.
• Experience investigating quality issues and resolving compliance related challenges.
• Knowledge of manufacturing and distribution processes within regulated environments.
• Strong analytical, problem solving, communication, and negotiation skills.
• Experience working with cross functional teams to resolve product and process issues.

Preferred Qualifications:

• Experience supporting quality audits and regulatory inspections.
• Knowledge of validation documentation and quality systems.
• Experience with warehouse management systems and quality hold processes.
• Experience managing supplier audit records and master data.
• Experience supporting new product introduction activities.

Benefits: The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, paid holidays annually as applicable.