Onsite QA Batch Release Specialist I

ProKidney Corp.; Winston-Salem (NC); On-site; USD 60,000 - 75,000; Full time

Job summary

ProKidney Corp. in Winston-Salem, NC is seeking a Quality Assurance Specialist I, Batch Release Contractor to perform routine review and documentation for material disposition, under established procedures. The role emphasizes cGMP compliance, data integrity, and collaboration with Manufacturing, QA, and Supply Chain.

It is an onsite contract position with potential overtime. Candidates should have a life sciences or related degree with at least two years in regulated environments and

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 elevate concerns appropriately.
• Proficiency with Microsoft Word and Excel; exposure to electronic quality or document management systems preferred.

Responsibilities

• Review routine executed manufacturing, filling, packaging, labeling, and analytical records using approved procedures and checklists.
• Verify documentation for completeness, legibility, traceability, required signatures, calculations, and adherence to data integrity expectations.
• 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 accurate batch review status, deficiencies, and follow-up actions in approved GMP systems and trackers.
• Support follow-up on missing information, corrections, and documentation responses with Manufacturing, Quality Control, and Supply Chain.
• Assist with deviation, investigation, CAPA, change control, and controlled-document activities as assigned.
• Perform routine production-area observations and promptly report potential cGMP concerns.
• Complete required training, maintain current knowledge of assigned procedures, and participate in continuous improvement activities.
• Perform other quality-related duties as assigned.

Skills

Attention to detail

Documentation review

Data integrity

MS Word & Excel

Education

Bachelor's degree or associate degree with 2+ years in regulated environment

Job description

ProKidney Corp. in Winston-Salem, NC is seeking a Quality Assurance Specialist I, Batch Release Contractor to perform routine review and documentation for material disposition, under established procedures. The role emphasizes cGMP compliance, data integrity, and collaboration with Manufacturing, QA, and Supply Chain.

It is an onsite contract position with potential overtime. Candidates should have a life sciences or related degree with at least two years in regulated environments and