Quality Assurance Specialist
Core
Evaluate and review clinical and commercial drug batches to ensure quality and compliance with cGMP standards in a penicillin manufacturing facility.
Role type
Quality Assurance Specialist (Manufacturing)
Builds
Safe and effective pharmaceutical products for patients
Domain
Pharmaceutical manufacturing / Quality Assurance
Required skills
GxP knowledge, statistical process control, deviation management, change control, root cause analysis, batch record review, inspection readiness, risk management
Preferred skills
Manufacturing site experience, ERP system proficiency, AI tool usage (ChatGPT/Copilot), independent problem solving
Technologies
Enterprise Resource Planning systems, AI tools (ChatGPT, Microsoft Copilot)
Responsibilities
Evaluate and review drug batches, ensure documents meet specifications, identify deviations, approve investigations, oversee change control, maintain inspection readiness, assist in real-time compliance error detection, lead Quality Risk Management assessments
Seniority
Mid-level, hands-on IC
