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.
- 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 escalate 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.