QA Specialist I - Supplier Quality
Core
Ensuring quality aspects of supplier quality management for suppliers providing raw materials, components, contract test labs, and services for GMP operations.
Role type
Supplier Quality Specialist (GMP)
Builds
Supplier Qualification program execution across facilities
Domain
Pharmaceutical/Biotech/Medical Device Quality Compliance
Deliverable
client delivery
Required skills
Supplier audit observation tracking, supplier change notification monitoring, non-conformance and complaint handling, supplier quality assurance agreement management, supplier risk assessment support, annual product quality review support, SOP writing and revision
Preferred skills
GMP quality systems experience in pharma/biotech/medical device, regulatory guidance familiarity (FDA 21CFR Part 210, 211 & 820; EMA, ICH), cross-functional team collaboration
Technologies
MS Office (Word, Excel)
Responsibilities
Follow up and track supplier audit observations, monitor and communicate supplier change notifications, review audit responses, draft and manage supplier quality agreements, support supplier risk assessments, support annual product quality reviews, write and revise SOPs
Seniority
Individual Contributor, 3+ years experience preferred
