Global Quality Import/Export Specialist

Uniphar Group; North Carolina; On-site; USD 28,000 - 40,000; Full time

Job summary

Uniphar seeks a Quality Import / Export Specialist to oversee commercial import/export activities and ensure GDP compliance. You will review shipments, documents, and licenses, coordinating with Operations and customs brokers to resolve issues while maintaining QMS alignment.

Requirements include five+ years in regulated life sciences QA, experience with import/export and CAPA processes, and a bachelor’s degree. This role focuses on regulatory readiness and risk mitigation within US operations.

Qualifications

• Five (5)+ years in a regulated life sciences Quality Assurance environment.
• Experience supporting pharmaceutical distribution, import/export operations, or GDP-regulated activities.
• Experience reviewing import/export documentation and shipment records.
• Experience supporting deviations, investigations, CAPAs, and Quality Management Systems.
• Working knowledge of FDA-regulated pharmaceutical distribution activities.
• Bachelor’s degree

Responsibilities

• Provide quality oversight of commercial import/export activities.
• Review documentation for regulatory compliance and accuracy.
• Coordinate with operations, brokers, and customers to resolve issues.
• Ensure required approvals are obtained before release for import/export.
• Identify and elevate potential compliance risks and CAPAs.
• Maintain records per retention requirements and QMS.
• Support development and revision of import/export procedures.
• Monitor quality metrics and support inspection readiness.

Skills

Quality Assurance

GDP knowledge

Documentation review

Cross-functional collaboration

Risk management

Quality systems

Microsoft Office

FDA-regulated distribution

Education

Bachelor’s degree

Tools

Microsoft Office

Job description

Uniphar seeks a Quality Import / Export Specialist to oversee commercial import/export activities and ensure GDP compliance. You will review shipments, documents, and licenses, coordinating with Operations and customs brokers to resolve issues while maintaining QMS alignment.

Requirements include five+ years in regulated life sciences QA, experience with import/export and CAPA processes, and a bachelor’s degree. This role focuses on regulatory readiness and risk mitigation within US operations.