ProKidney Corp. · 2 hours ago
Manager, QA Floor Support
Winston-Salem, NC
Full-time
Onsite
Senior Level
5+ years expProKidney Corp. is a company focused on developing innovative solutions in the healthcare sector. The Quality Assurance On-The-Floor (OTF) Manager will lead the QA On-The-Floor program, ensuring compliance with cGMP standards while collaborating closely with Manufacturing, Quality Control, and other teams.
Health CareTherapeutics
No H1B
Responsibilities
Lead the team responsible for on-the-floor support of manufacturing, including reviewing documentation and providing real-time support during changeovers and other manufacturing issues
Develop direct reports and ensure completion of required training
Review and approve activities performed by direct reports
Delegate activities to support team responsibilities
Ensure all on-the-floor support personnel are gowning qualified at all times
Oversee and generate quality on-the-floor support schedules aligned with the manufacturing schedule
Execute floor support activities, including routine walkthroughs of manufacturing suites, partnering with manufacturing on suite maintenance, implementing Quality best practices, and troubleshooting issues as they arise
Perform real-time quality batch record review and identify potential deviations requiring reporting
Document observations identified during manufacturing runs and escalate or resolve issues as appropriate
Review documentation related to GMP activities such as forms, logbooks, testing documentation, Building Management System alarms, equipment alarms/cleaning, and kitting processes
Ensure all quarantined materials are stored appropriately post-manufacturing activities
Communicate significant Quality issues to key stakeholders promptly
Interact frequently with direct manager, subordinates, and cross-functional peers to align on quality decisions
Make or support quality decisions impacting operations, ensuring appropriate escalation and resolution of complex issues
Identify risks and communicate quality and GMP process/system gaps
Review and approve facility alarms, work order requests, and return-to-service documentation
Support, review, and approve Deviations and Change Controls associated with operational activities, batch records, or manufacturing improvements
Train new employees on Batch Record Review, Floor Support activities, and Room Release processes
Collaborate effectively in a dynamic, cross-functional matrix environment, managing multiple projects in a fast-paced setting
Author and review SOPs and policies to ensure compliance with regulations and cGMP operations
Participate in quality-focused teams across ProKidney’s functions
Support internal audits to ensure adherence to cGMP, SOPs, and manufacturing documentation
Establish and follow procedures for clear and accurate documentation of equipment operation, process instructions, and data
Perform other duties as assigned by manager
Qualification
Required
Bachelor's degree in applied science or a related field
5+ years of relevant experience in Quality Assurance or Quality Control, ideally within cGMP aseptic manufacturing operations
Strong organizational, analytical, and time management skills
Ability to work well in a team environment with a positive attitude and willingness to assist other areas of the organization
Excellent verbal and written communication skills with a strong focus on attention to detail
Ability to handle multiple tasks simultaneously while maintaining a strong attention to detail
Demonstrated working knowledge of FDA, EU, and ICH Regulatory requirements and guidelines
Physical ability to perform frequent tasks requiring strength and mobility; flexible scheduling may be required
Any equivalent combination of education, experience, and training may substitute
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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