Onsite GMP QA Lead — Floor & In-Process

ProKidney; Winston-Salem (NC); On-site; USD 70,000 - 100,000; Full time

Job summary

ProKidney is seeking a Quality Assurance Specialist III for floor support in Winston‑Salem, NC. This on‑site role requires full gowning in classified manufacturing environments and real‑time QA oversight.

You will perform on‑floor review of batch records, support deviation investigations, CAPAs, and line clearance, collaborating with Manufacturing, QC, and Facilities to ensure cGMP compliance. A Bachelor’s degree and 5 years of QA GMP experience are required; aseptic manufacturing experience is

Qualifications

• Bachelor's degree in an applied science or equivalent experience.
• 5 years of QA experience in a GMP-regulated environment.
• Aseptic manufacturing experience preferred.

Responsibilities

• Provide QA review of moderate‑complexity manufacturing operations in classified environments.
• Maintain continuous on‑floor presence to support compliance, production activities, and issue resolution.
• Conduct complex in‑process batch record reviews and evaluate documentation for compliance and accuracy.
• Review manufacturing records, environmental monitoring data, and related documentation.
• Perform and verify line clearance activities for assigned processes.
• Identify, document, and resolve standard quality issues; elevate higher‑risk or non‑routine issues as required.
• Support and contribute to deviation investigations, CAPAs, and remediation activities.
• Review and approve facility alarms, work orders, and return‑to‑service documentation.
• Participate in internal audits, inspections, and cross‑functional quality initiatives.
• Follow all gowning, safety, and cleanroom behavior requirements.

Skills

cGMP knowledge

Documentation skills

Analytical thinking

Problem solving

Cross-functional collaboration

Education

Bachelor's degree in applied science or equivalent

Job description

ProKidney is seeking a Quality Assurance Specialist III for floor support in Winston‑Salem, NC. This on‑site role requires full gowning in classified manufacturing environments and real‑time QA oversight.

You will perform on‑floor review of batch records, support deviation investigations, CAPAs, and line clearance, collaborating with Manufacturing, QC, and Facilities to ensure cGMP compliance. A Bachelor’s degree and 5 years of QA GMP experience are required; aseptic manufacturing experience is