QA Specialist II, Batch Release - Onsite

ProKidney; White Settlement (TX); On-site; USD 65,000 - 90,000; Part time

Job summary

ProKidney is seeking a Quality Assurance Specialist II, Batch Release (contractor) to ensure documentation is complete, accurate, and compliant for material and product disposition. The role partners across Manufacturing, Quality Control, Supply Chain, and other teams to resolve issues and support timely release decisions.

The contractor position is onsite in Winston-Salem, NC, with schedule flexibility and overtime possible based on business needs.

Qualifications

• Bachelor’s degree in life sciences, engineering, or related field with experience in regulated environments.
• Working knowledge of cGMP, quality systems, deviation management, and CAPA processes.
• Experience reviewing batch records and documentation for accuracy and traceability.
• Familiarity with FDA/EU/ISO regulatory frameworks preferred.
• Strong attention to detail and ability to manage multiple tasks.

Responsibilities

• Review manufacturing, packaging, labeling, and analytical records for completeness, accuracy, traceability, data integrity, and compliance with procedures; identify discrepancies and coordinate resolution before disposition.
• Compile and perform initial quality review of batch disposition documentation and verify records before recommending batch disposition.
• Maintain accurate records in GMP databases and tracking systems.
• Monitor production activities for cGMP compliance and document escalated issues.
• Support deviation investigations, root cause analysis, CAPAs, and effectiveness activities.

Skills

cGMP knowledge

Deviation management

Root cause analysis

CAPA processes

Quality systems

Education

Bachelor's degree in life sciences or related field

Associate degree with relevant experience

Tools

GMP databases

Job description

ProKidney is seeking a Quality Assurance Specialist II, Batch Release (contractor) to ensure documentation is complete, accurate, and compliant for material and product disposition. The role partners across Manufacturing, Quality Control, Supply Chain, and other teams to resolve issues and support timely release decisions.

The contractor position is onsite in Winston-Salem, NC, with schedule flexibility and overtime possible based on business needs.