Quality Specialist II
Core
Client-facing Quality Specialist ensuring compliance and quality for clinical trial product storage and repository operations.
Role type
Quality Specialist II (Client-facing)
Builds
Quality compliance and audit readiness for clinical trial products
Domain
Life Sciences / Clinical Trials / Pharmaceutical Storage
Deliverable
client delivery
Required skills
Client audit hosting, batch record review, validation protocol review, quality system documentation, cross-functional coordination, data integrity surveillance
Preferred skills
TrackWise experience, label review, regulated industry experience
Technologies
TrackWise, Microsoft Office
Responsibilities
Prepare for and host external client audits, review master batch records and validation protocols, manage post-audit observations in TrackWise, review shipment labels, support quality oversight in storage areas
Seniority
Mid-level, hands-on IC

