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Quality Assurance Specialist 2, Batch Release Contractor at ProKidney - ApplyBlast

Quality Assurance Specialist 2, Batch Release Contractor

ProKidney

18 days ago

3.9 on Glassdoor

Winston-Salem, North Carolina, United States

Onsite

Contract

Medior

0 applicants

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About this role

The Quality Assurance Specialist II, Batch Release Contractor supports Quality Operations by conducting detailed reviews of manufacturing, packaging, labeling, and laboratory records to ensure compliance with cGMP requirements and approved procedures. The role involves verifying documentation completeness, resolving quality events, and collaborating with cross-functional teams to support compliant material and product disposition. This onsite position in Winston-Salem, NC requires schedule flexibility and is not eligible for remote work or ProKidney benefits.

Responsibilities

Review executed manufacturing and laboratory records for compliance and accuracy
Compile and perform initial quality review of batch disposition documentation
Support deviation investigations and root cause analysis for quality events

Skills

About ProKidney

prokidney.com

Headquarters

Winston-Salem, North Carolina, United States

Company Size

51-200 employees

View Profile

ProKidney is a late clinical‑stage biotechnology company developing a first‑in‑class cell therapy candidate to treat advanced chronic kidney disease (CKD). Their lead program aims to preserve kidney function in patients who have limited therapeutic options and to transform the therapeutic landscape for progressive CKD. As a pioneer in CKD therapeutics, ProKidney is advancing clinical development to demonstrate safety and efficacy of regenerative approaches. The company focuses on addressing a major unmet need in kidney disease through novel cell‑based treatments.