Senior QA Specialist – GMP & Cleanroom

ProKidney Corp.; Winston-Salem (NC); On-site; USD 80,000 - 100,000; Full time

Job summary

ProKidney Corp. seeks a QA Specialist III to provide real‑time QA support within classified manufacturing areas, including cleanrooms.

On‑site, full‑time role requiring gowning and collaboration with Manufacturing, QC, Facilities, and other stakeholders to ensure compliant operations. The ideal candidate has a Bachelor’s in an applied science and at least 5 years of QA experience in a GMP environment, with aseptic manufacturing experience preferred.

Qualifications

• Bachelor’s degree in an applied science field or equivalent experience.
• 5 years of QA experience in a GMP‑regulated manufacturing or quality 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; escalate 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

Judgement

Documentation

Cross‑functional communication

Prioritization

Education

Bachelor's degree in an applied science field

Job description

ProKidney Corp. seeks a QA Specialist III to provide real‑time QA support within classified manufacturing areas, including cleanrooms.

On‑site, full‑time role requiring gowning and collaboration with Manufacturing, QC, Facilities, and other stakeholders to ensure compliant operations. The ideal candidate has a Bachelor’s in an applied science and at least 5 years of QA experience in a GMP environment, with aseptic manufacturing experience preferred.