Quality Assurance and Change Control Specialist
Core
Manage factory quality systems, document control, and change control processes to ensure regulatory compliance and product safety.
Role type
Quality Assurance and Change Control Specialist
Builds
Quality management systems, controlled documents, and validated change implementations (via careerplan.io/jobs/E9-00A-02-D65-quality-assurance-and-change-control-specialist)
Domain
Food technology / Industrial manufacturing
Required skills
GMP compliance, SOP lifecycle management, change control procedures, risk assessment, CAPA management, technical writing, process analysis
Preferred skills
Chemical engineering degree, food technology background, ERP systems experience
Technologies
Microsoft Office (Excel, Word, PowerPoint), Priority ERP
Responsibilities
Oversee factory policy systems and ensure accurate, compliant documentation; Manage full lifecycle of SOPs including drafting, review, approval, and periodic updates; Execute change control requests for equipment, processes, software, and raw materials; Conduct risk assessments for proposed changes; Support internal and external audits and manage corrective actions; Deliver GMP and quality training to factory staff
Seniority
Mid-level, hands-on specialist