ProKidney Corp. · 15 hours ago
Manager, QA Floor Support
United States
Full-time
Remote
Mid, Senior Level
5+ years expProKidney Corp. is a company focused on quality assurance in clinical and commercial manufacturing activities. They are seeking a Quality Assurance On-The-Floor Manager to lead the QA team, ensure compliance with GMP regulations, and collaborate with various departments to maintain production quality.
Health CareTherapeutics
No H1B
Responsibilities
Manage, develop, and coach the QA On-the-Floor team; ensure training, qualification, and performance expectations are met
Assign and approve work performed by direct reports, including documentation reviews and floor support activities
Maintain team readiness by ensuring all OTF personnel remain gown-qualified and trained on current procedures
Oversee and publish daily/weekly QA floor support schedules aligned with the manufacturing schedule
Provide real-time QA presence on the manufacturing floor, including routine walkthroughs, observation of operations, support during processing, and reinforcement of cleanroom behaviors
Identify, document, and escalate GMP issues or atypical events during manufacturing
Perform and/or oversee real-time batch record review to ensure accuracy and completeness
Make routine QA decisions related to room/equipment release, line clearance, and documentation accuracy
Support and/or approve alarms, return-to-service documentation, deviations, change controls, and other quality records related to floor operations
Partner with Manufacturing to troubleshoot operational issues and implement corrective actions
Ensure timely review of GMP documents (forms, logbooks, testing documentation, alarms, kitting, etc.)
Ensure quarantined materials are stored and managed appropriately post-manufacturing
Author, revise, and review SOPs and quality procedures related to on-the-floor operations
Support internal audits, regulatory inspections, and compliance initiatives
Collaborate in a fast-paced, matrixed environment to ensure alignment on quality expectations and operational priorities
Participate in cross-functional quality teams and process improvement initiatives
Maintain standards for accurate documentation, data integrity, and compliance in all QA-OTF activities
Perform other duties as assigned
Qualification
Required
Bachelor's degree in applied science or related field
5+ years relevant QA experience in cGMP aseptic manufacturing, preferred as Quality on the floor
Proven, hands-on knowledge of commercial GMP regulations for sterile manufacturing
Strong organizational, analytical, and time management skills
Ability to work well in a team environment with positive attitude
Excellent communication skills with strong attention to detail
Ability to handle multiple tasks simultaneously
Demonstrated working knowledge of FDA, EU, and ICH regulatory requirements
Physical ability to perform frequent tasks requiring strength and mobility
Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship
Company
ProKidney Corp.
ProKidney, a pioneer in the treatment of chronic kidney disease through innovations in cellular therapy, was founded in 2015 after a decade of research.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$345MKey Investors
Social Capital
2024-06-11Post Ipo Equity· $140M
2022-07-12Post Ipo Equity· $205M
2022-07-12IPO
Leadership Team
Bruce Culleton
Chief Executive Officer
Recent News
2026-01-06
2026-01-03
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