QA Batch Release Specialist I

ProKidney; White Settlement (TX); On-site; USD 55,000 - 70,000; Full time

Job summary

ProKidney is seeking a Quality Assurance Specialist I, Batch Release to perform routine review and administrative activities supporting material and product disposition. Under established procedures, you will review manufacturing and lab documentation for completeness, accuracy, and compliance and escalate issues as needed.

This contractor role is onsite in Winston Salem, NC with overtime as required and does not include ProKidney benefits.

Qualifications

• Bachelor's degree in life sciences, engineering, quality, or a related field; or an associate degree with at least two years of relevant experience in a regulated environment.
• Foundational understanding of cGMP requirements, controlled documentation, and data integrity principles.
• Ability to follow detailed procedures, recognize documentation errors, and escalate concerns appropriately.
• Strong attention to detail, organization, and written and verbal communication skills.
• Proficiency with Microsoft Word and Excel; exposure to electronic quality or document management systems preferred.

Responsibilities

• Review routine manufacturing, filling, packaging, labeling, and analytical records using approved procedures and checklists.
• Verify documentation for completeness, legibility, traceability, required signatures, calculations, and data integrity.
• Identify documentation discrepancies, communicate findings, and escalate concerns appropriately.
• Compile batch disposition documentation and confirm records are available for review.
• Enter and maintain batch review status, deficiencies, and follow-up actions in GMP systems.
• Support follow-up on missing information and documentation responses with Manufacturing, QC, and Supply Chain.
• Assist with deviation, investigation, CAPA, change control, and controlled-document activities as assigned.
• Perform routine production-area observations and report potential cGMP concerns.
• Complete required training and participate in continuous improvement activities.

Skills

Attention to detail

Documentation review

cGMP knowledge

Excel

Written communication

Education

Bachelor's degree in life sciences

Associate degree with 2+ years in a regulated environment

Tools

MS Word

Quality management systems

Job description

ProKidney is seeking a Quality Assurance Specialist I, Batch Release to perform routine review and administrative activities supporting material and product disposition. Under established procedures, you will review manufacturing and lab documentation for completeness, accuracy, and compliance and escalate issues as needed.

This contractor role is onsite in Winston Salem, NC with overtime as required and does not include ProKidney benefits.