Quality Specialist
Core
Provide QMS support to the Senior Quality Manager to ensure compliant execution, monitoring, and continuous improvement of Quality Management Systems and Quality Control in line with certification requirements and customer expectations.
Role type
Quality Specialist (QA/QC)
Builds
Production releases, complaint investigations, and audit support for life sciences and diagnostics products
Domain
Life sciences, diagnostics, biotechnology, pharmaceuticals
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Assurance, Quality Engineering, outlier analysis, complaint investigation, audit support, documentation control, change control, deviation handling, CAPA, risk assessment, calibration, validation, ISO 9001, GMP, GDP
Preferred skills
Lean tools (DBS), internal audit against ISO 9001/GMP, pharmaceutical industry QA/Lab experience
Technologies
Veeva
Responsibilities
Perform production release activities as a Quality Assurance representative; perform destructive analysis on returned complaint samples; perform outlier analysis to identify abnormal data points; support Quality Assurance activities including audits and documentation control.
Seniority
Mid-level, hands-on IC