Quality Assurance Specialist
Core
Ensuring quality oversight of clinical trial conduct and continuous improvement of the quality system framework.
Role type
Quality Assurance Specialist (Clinical Research)
Builds
Quality system framework, audit plans, SOPs, vendor management programs
Domain
Life Sciences / Clinical Research / cGXP
Deliverable
dashboards & analysis
Required skills
cGXP regulations knowledge, Quality Management Standards (ISO 9001), internal audit execution, vendor management, SOP development, computer system validation
Preferred skills
ISO 9001 Lead Auditor Certification, Compliance Quest experience, electronic quality management systems experience
Technologies
Compliance Quest
Responsibilities
Leading client audit preparation and follow-up, conducting internal audits of cGXP departments, executing vendor management and quality programs, assisting with SOP development, overseeing computer system validation activities
Seniority
Mid-level, hands-on IC