Manager, QA Floor Support

Responsibilities

• Manage, develop, and coach the QA On-the-Floor team
• Oversee daily/weekly QA floor support schedules aligned with manufacturing
• Provide real-time QA presence on the manufacturing floor and reinforce cleanroom behaviors
• Identify, document, and escalate GMP issues or atypical events
• Perform and oversee real-time batch record review
• Make routine QA decisions related to room/equipment release and line clearance
• Support and approve deviations, change controls, and other quality records
• Author, revise, and review SOPs and quality procedures
• Support internal audits and regulatory inspections

Requirements

• Bachelor’s degree in applied science or related field
• 5+ years relevant QA experience in cGMP aseptic manufacturing
• Hands-on knowledge of commercial GMP regulations for sterile manufacturing
• Working knowledge of FDA, EU, and ICH regulatory requirements
• Strong organizational, analytical, and time management skills
• Physical ability to perform frequent tasks requiring strength and mobility

About the Company

ProKidney is a biotechnology company focused on clinical and commercial manufacturing activities at their cGMP site.