Specialist III, Quality Assurance (Quality Systems)
Core
Subject-matter expert responsible for the administration, oversight, compliance, and continuous improvement of Quality Management System (QMS) processes at a pharmaceutical manufacturing site.
Role type
Senior Quality Systems Specialist (Pharmaceutical Manufacturing)
Builds
Sustained state of inspection readiness and compliant quality systems for Gilead Alberta
Domain
Pharmaceutical manufacturing / Biotechnology / Quality Assurance
Required skills
GMP requirements interpretation, Quality System procedures, deviation management, CAPA, change control, SOP authoring, quality metrics analysis, training program oversight, cross-functional collaboration
Preferred skills
None stated
Technologies
Electronic quality systems, electronic learning systems
Responsibilities
Provide independent oversight and subject-matter expertise for assigned Quality Management System processes; Lead and support activities required to maintain a sustained state of inspection readiness; Develop, analyze, trend, and report Quality System metrics and key performance indicators; Provide Quality Systems expertise and oversight for deviation, CAPA, and change control processes; Author, revise, review, and maintain SOPs, work instructions, forms, standards, and other controlled Quality documents; Provide oversight and subject-matter expertise for site training programs and electronic learning systems.
Seniority
Senior, hands-on IC
