Specialist I, Quality Assurance (Quality Systems)

Specialist I, Quality Assurance (Quality Systems) role supporting the administration, maintenance, and continuous improvement of Gilead's Quality Management System in Alberta. The position ensures regulatory compliance, inspection readiness, and effective execution of quality system processes across the manufacturing site.

Responsibilities

• Administer and maintain Quality Management System processes and documentation
• Support inspection readiness activities and prepare for Health Canada, FDA, and customer audits
• Collect, compile, and report quality metrics for management review
• Support deviation, CAPA, and change control process administration
• Provide user support for electronic quality systems and assist with system testing and enhancements

Requirements

• Master's degree or 0+ years regulated industry experience
• Bachelor's degree or 2+ years regulated industry experience
• Associate's degree or 4+ years regulated industry experience
• Working knowledge of Microsoft Office applications
• Basic understanding of current Good Manufacturing Practices (GMPs)
• Strong verbal, written, and interpersonal communication skills
• Pharmaceutical industry experience preferred