Onsite QA Batch Release Specialist (Contractor)

ProKidney Corp.; Winston-Salem (NC); On-site; USD 39,000 - 58,000; Full time

Job summary

ProKidney Corp. in Winston-Salem, NC seeks a Quality Assurance Specialist II, Batch Release (contractor) to review manufacturing and QC records for completeness, accuracy, and regulatory compliance.

The role partners with Manufacturing, Quality Control, Supply Chain, and other functions to resolve issues and support timely disposition. Responsibilities include quality reviews of batch documentation, adherence to cGMP, deviation investigations, CAPAs, and continuous improvement of quality

Qualifications

• Bachelor's degree in life sciences or related field with at least two years of relevant experience in a regulated environment.
• Familiarity with cGMP, quality systems, deviation management, and CAPA processes.
• Experience reviewing batch records, manufacturing documentation, or quality documentation for completeness and data integrity.

Responsibilities

• Review executed manufacturing, filling, packaging, labeling, and analytical records for completeness, accuracy, traceability, data integrity, and compliance; identify discrepancies and coordinate resolution.
• Perform initial quality review of batch disposition documentation; confirm records are complete and deviations/investigations are resolved per procedures before disposition.
• Maintain accurate records in GMP databases and tracking systems; perform data entry and status updates.
• Monitor production and non-production activities for cGMP compliance and promptly document issues.
• Support deviation investigations, root cause analysis, CAPAs, and effectiveness activities; evaluate impact of quality events on materials and disposition timelines.
• Review and provide input on SOPs, change controls, protocols, and other controlled documents.

Skills

Attention to detail

Documentation management

Regulatory awareness

Cross-functional collaboration

Education

Bachelor's degree in life sciences or related field

Associate degree with 4+ years of experience

Job description

ProKidney Corp. in Winston-Salem, NC seeks a Quality Assurance Specialist II, Batch Release (contractor) to review manufacturing and QC records for completeness, accuracy, and regulatory compliance.

The role partners with Manufacturing, Quality Control, Supply Chain, and other functions to resolve issues and support timely disposition. Responsibilities include quality reviews of batch documentation, adherence to cGMP, deviation investigations, CAPAs, and continuous improvement of quality