Quality Assurance Specialist III
Core
Provide on-site advanced-level hands-on support for GxP laboratory services and kitting production, managing document control, internal audits, and quality inspection/release of materials and products.
Role type
Senior IC Quality Assurance Specialist (GxP/Life Sciences)
Builds
Production of regulated laboratory services and kitted products
Domain
Life Sciences / Regulated Manufacturing (GxP)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GxP compliance, internal auditing, CAPA, root cause analysis, document control, batch release, supplier quality management, change management, data analysis, process mapping
Preferred skills
Clinical quality experience, lead auditor certification, Society for Quality Assurance (SQA) membership
Technologies
Microsoft Office suite (Word, Excel, PowerPoint), databases/spreadsheets
Responsibilities
Lead internal and supplier audits; manage document and record control systems; inspect and release raw materials, components, and finished products; analyze quality metrics and report to management; support validation activities; conduct training and act as a change agent for continuous improvement.
Seniority
Senior, hands-on IC