QA Batch Release Specialist I - Contractor

ProKidney Corp.; Winston-Salem (NC); On-site; USD 34,000 - 55,000; Full time

Job summary

ProKidney Corp. in Winston-Salem, NC seeks a Quality Assurance Specialist I, Batch Release Contractor to review manufacturing and analytical records for completeness and compliance. This contractor role requires attention to data integrity, adherence to procedures, and timely escalation of discrepancies.

Onsite work with overtime as needed. The position emphasizes cGMP knowledge, document control, and collaboration with Manufacturing, QC, and Supply Chain to finalize batch dispositions.

Qualifications

• Bachelor’s degree in life sciences, engineering, quality, or related field; or associate degree with two years in regulated environment.
• Foundational understanding of cGMP requirements, controlled documentation, and data integrity principles.
• Ability to follow detailed procedures, recognize documentation errors, and elevate concerns appropriately.
• Strong attention to detail, organization, and written and verbal communication skills.
• Proficiency with 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 elevate potential compliance or release-impacting issues.
• Compile batch disposition documentation and confirm required records are available for review.
• Enter and maintain batch review status, deficiencies, and follow-up actions in GMP systems and trackers.
• Support follow-up on missing information, corrections, 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.
• Perform other quality-related duties as assigned.

Skills

Attention to detail

Documentation

Regulatory compliance

Communication

GMP data integrity

Education

Bachelor’s degree in life sciences/related field

Associate degree with 2+ years in regulated environment

Tools

Microsoft Word

Excel

Job description

ProKidney Corp. in Winston-Salem, NC seeks a Quality Assurance Specialist I, Batch Release Contractor to review manufacturing and analytical records for completeness and compliance. This contractor role requires attention to data integrity, adherence to procedures, and timely escalation of discrepancies.

Onsite work with overtime as needed. The position emphasizes cGMP knowledge, document control, and collaboration with Manufacturing, QC, and Supply Chain to finalize batch dispositions.