QA Specialist II - Supplier Quality
Core
Ensuring supplier compliance with GMP standards for raw materials, components, and services across biopharma operations.
Role type
Senior IC Quality Assurance Specialist (Supplier Quality)
Builds
Supplier qualification programs and compliance frameworks for GMP operations
Domain
Biopharma / Pharmaceutical manufacturing / Quality Compliance
Required skills
Supplier audit execution, GMP compliance monitoring, regulatory guidance knowledge (FDA/EMA/ICH), change notification management, non-conformance tracking, SOP development, cross-functional collaboration, KPI tracking
Preferred skills
Bachelor of Science in relevant field, 5+ years QA GMP experience, pharmaceutical/biotech/medical device environment experience, MS Office proficiency (Word, Excel, Access, Visio)
Responsibilities
Schedule and conduct supplier audits to evaluate compliance with SOPs and regulatory standards; track and ensure closure of audit observations; monitor and reconcile supplier change notifications and non-conformances; review audit responses to prevent deficiency recurrence; draft and manage supplier quality assurance and non-disclosure agreements; support supplier risk assessments and annual product quality reviews; maintain KPI metrics for the supplier qualification program; write and revise Standard Operating Procedures (SOPs)
Seniority
Mid-Senior, hands-on IC
