Quality Assurance Specialist 2, Batch Release Contractor

ProKidney; White Settlement (TX); On-site; USD 65,000 - 90,000; Part time

Job summary

ProKidney is seeking a Quality Assurance Specialist II, Batch Release (contractor) to ensure documentation is complete, accurate, and compliant for material and product disposition. The role partners across Manufacturing, Quality Control, Supply Chain, and other teams to resolve issues and support timely release decisions.

The contractor position is onsite in Winston-Salem, NC, with schedule flexibility and overtime possible based on business needs.

Qualifications

• Bachelor’s degree in life sciences, engineering, or related field with experience in regulated environments.
• Working knowledge of cGMP, quality systems, deviation management, and CAPA processes.
• Experience reviewing batch records and documentation for accuracy and traceability.
• Familiarity with FDA/EU/ISO regulatory frameworks preferred.
• Strong attention to detail and ability to manage multiple tasks.

Responsibilities

• Review manufacturing, packaging, labeling, and analytical records for completeness, accuracy, traceability, data integrity, and compliance with procedures; identify discrepancies and coordinate resolution before disposition.
• Compile and perform initial quality review of batch disposition documentation and verify records before recommending batch disposition.
• Maintain accurate records in GMP databases and tracking systems.
• Monitor production activities for cGMP compliance and document escalated issues.
• Support deviation investigations, root cause analysis, CAPAs, and effectiveness activities.

Skills

cGMP knowledge

Deviation management

Root cause analysis

CAPA processes

Quality systems

Education

Bachelor's degree in life sciences or related field

Associate degree with relevant experience

Tools

GMP databases

Job description

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 escalated 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 escalated 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; escalated 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.
• Maintain current knowledge of relevant regulations, industry standards, and quality practices.
• Perform other duties and quality-related assignments as needed.

Minimum Qualifications

• Bachelor's degree in life sciences, engineering, quality, or a related field and at least two years of relevant experience in a regulated pharmaceutical, biotechnology, medical device, or similar environment; or an associate degree and at least four years of relevant experience. An equivalent combination of education and experience may be considered.
• Working knowledge of cGMP requirements, quality systems, deviation management, root cause analysis, and CAPA processes.
• Experience reviewing executed batch records, manufacturing documentation, laboratory records, or quality documentation for completeness, accuracy, data integrity, traceability, and compliance; direct experience supporting material or product disposition in a pharmaceutical or biotechnology environment preferred.
• Familiarity with applicable FDA, EU, and ISO regulatory frameworks preferred.
• Strong attention to detail, sound judgment, and the ability to identify, communicate, and escalated quality risks.
• Ability to organize and prioritize multiple assignments, meet deadlines, and deliver accurate work in a fast-paced environment.

ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.