Supply Operation Quality Associate
Core
Evaluate and review clinical and commercial drug batches to ensure quality and compliance with cGMP standards.
Role type
Associate-level quality operations specialist
Builds
Safe and effective pharmaceutical products for patients
Domain
Pharmaceutical manufacturing / Quality Assurance
Required skills
batch evaluation, statistical process control, deviation management, change control, cGMP knowledge, inspection readiness, quality risk management
Preferred skills
manufacturing site experience, root cause analysis, ERP system proficiency, AI tool usage
Technologies
Enterprise Resource Planning systems, generative AI tools (ChatGPT, Microsoft Copilot)
Responsibilities
Review clinical and commercial drug batches; Ensure product and process documents meet specifications; Identify and address deviations from standards; Approve investigations and oversee change control; Maintain inspection readiness; Assist staff in real-time compliance error detection.
Seniority
Associate, entry-level with mentorship
