ProKidney
Manager, QA Floor Support
Winston-Salem, North Carolina, United States · Vp
Work authorization requiredDetected 26 days ago
Supply ChainProcess ImprovementGMPFDA RegulatoryLeadershipCommunicationCollaborationTime Management
About the role
- The Quality Assurance On-The-Floor (OTF) Manager is responsible for leading the QA On-The-Floor team and providing real-time quality oversight of clinical and commercial manufacturing activities at ProKidney's cGMP site.
- This position is located fully onsite in Winston Salem, NC.
- Quality Decision Making & Issue Resolution
Responsibilities
- 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.
- Manufacturing Floor Support & Quality Oversight
- 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.
- 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.
- Support internal audits, regulatory inspections, and compliance initiatives.
- Collaborate in a fast-paced, matrixed environment to ensure alignment on quality expectations and operational priorities.
- Maintain standards for accurate documentation, data integrity, and compliance in all QA-OTF activities.
Nice to have
- 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.
Visa & Work Authorization
- Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.
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This listing is sourced directly from ProKidney's careers page and normalized into a canonical job model.