Quality Specialist
Core
Managing quality activities including non-conformance, complaints, change control, and site quality systems at a manufacturing facility.
Role type
Quality Specialist (Manufacturing)
Builds
Ensures compliance with QMS and regulatory standards for life sciences diagnostics and biotechnology products.
Domain
Life Sciences / Diagnostics / Biotechnology / Manufacturing
Deliverable
client delivery
Required skills
Root cause analysis, CAPA management, change control, audit support, data integrity principles, quality tools (5 Why, Ishikawa, SPC, Pareto, FMEA), regulatory standards knowledge
Preferred skills
Internal audit, external audit support
Technologies
Veeva, Microsoft Office (Excel, PowerPoint)
Responsibilities
Drive compliance with QMS and regulatory standards; Monitor and report QMS performance; Investigate non-conformances and implement CAPA; Act as SME for Complaint Handling Program; Support change control, document management, and audit readiness
Seniority
Mid-level, hands-on IC