Investigator, Mfg Compliance (Contract)

ProKidney(1 month ago)

Winston-Salem, North Carolina, United StatesOnsiteContractSenior$104,544 - $144,492 (estimated)Quality Assurance

About this role

The Technical Investigator is a contract role focused on maintaining quality systems and cGMP compliance within a cell therapy department by overseeing investigations, change controls, and CAPAs. The position supports cross-functional collaboration and documentation to protect product safety and quality while ensuring regulatory adherence. The role requires working on-site at the facility and interacting with multiple departments to complete investigations and implement corrective actions.

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Required Skills

Technical Writing
Data Gathering
Root Cause
Trend Analysis
Risk Assessment
Cause Mapping
Interviewing
Project Management
Meeting Facilitation
Conflict Resolution

+6 more

Qualifications

Undergraduate Degree in Science

About ProKidney

prokidney.com

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.