The Quality Assurance Specialist II, Batch Release (contractor) supports Quality Operations by conducting detailed reviews of executed manufacturing, packaging, labeling, and laboratory records used in material and product disposition. The role verifies that documentation is complete, accurate, traceable, and compliant with approved procedures, specifications, data integrity requirements, and current Good Manufacturing Practice (cGMP) requirements. The Specialist partners with Manufacturing, Quality Control, Supply Chain, and other functions to resolve documentation issues, assess quality events, and ensure release decisions are supported by complete and compliant records.

This is a contractor position located onsite in Winston-Salem, NC. This role is not eligible for ProKidney benefits or remote/hybrid work. Schedule flexibility, including overtime, may be required based on business needs.

Essential Duties and Responsibilities

Review executed manufacturing, filling, packaging, labeling, and analytical records for completeness, accuracy, traceability, data integrity, and compliance with approved procedures, specifications, acceptance criteria, and applicable regulatory requirements; identify discrepancies and coordinate their resolution before disposition.
Compile and perform initial quality review of batch disposition documentation, confirm that required manufacturing and testing records are complete, and verify that applicable deviations, investigations, and other quality events are assessed or resolved in accordance with approved procedures before recommending the batch for final disposition.
Maintain accurate and timely records in departmental GMP databases and tracking systems, including data entry, follow-up, and status updates.
Monitor production and non-production activities for compliance with cGMP requirements and promptly document and escalate observed issues.
Support deviation investigations, root cause analysis, corrective and preventive actions (CAPAs), and effectiveness activities; evaluate and document the
Review executed manufacturing, filling, packaging, labeling, and analytical records for completeness, accuracy, traceability, data integrity, and compliance with approved procedures, specifications, acceptance criteria, and applicable regulatory requirements; identify discrepancies and coordinate their resolution before disposition.
Compile and perform initial quality review of batch disposition documentation, confirm that required manufacturing and testing records are complete, and verify that applicable deviations, investigations, and other quality events are assessed or resolved in accordance with approved procedures before recommending the batch for final disposition.
Maintain accurate and timely records in departmental GMP databases and tracking systems, including data entry, follow-up, and status updates.
Monitor production and non-production activities for compliance with cGMP requirements and promptly document and escalate observed issues.
Support deviation investigations, root cause analysis, corrective and preventive actions (CAPAs), and effectiveness activities; evaluate and document the potential impact of quality events on affected materials, batches, and disposition timelines.
Review and provide quality input on standard operating procedures, change controls, protocols, and other controlled documents.
Support the implementation, maintenance, and continuous improvement of regulated quality systems and procedures.
Track and report batch review status, documentation deficiencies, release cycle times, recurring discrepancies, quality risks, and other performance indicators; escalate barriers that may affect compliant and timely disposition to Quality Management.
Participate in internal, customer, and regulatory audits and support timely responses to audit observations, as assigned.
Collaborate with Manufacturing, Quality Control, Supply Chain, Regulatory, and other cross-functional partners to resolve documentation discrepancies, obtain required information, communicate batch review status, and support compliant and timely material and product disposition.