ProKidney offers treatment of chronic kidney disease (CKD) through innovations in cellular therapy. Backed by North Carolina Biotechnology Center.
About the role
The Quality Assurance (QA) Specialist III provides independent, real-time QA support within classified manufacturing areas, including cleanrooms. The Specialist III applies solid cGMP expertise to perform documentation review, issue identification, escalation, and accurate records to ensure cGMP compliance.
What they're looking for
- Bachelor’s degree in an applied science field or equivalent experience
- 5 years of QA experience in a GMP‑regulated manufacturing or quality environment
- Aseptic manufacturing experience preferred
- Solid professional knowledge of cGMP regulations and quality systems
- Ability to apply judgement to moderately complex quality issues
- Strong documentation, analytical and problem-solving skills
More about this role
The Quality Assurance (QA) Specialist III provides independent, real-time QA support within classified manufacturing areas, including cleanrooms. The Specialist III applies solid cGMP expertise to perform documentation review, issue identification, escalation, and accurate records to ensure cGMP compliance. The role requires shift work, full gowning, on-floor presence, and collaboration with Manufacturing, Quality Control, Facilities, and other stakeholders to ensure compliant and efficient manufacturing operations.
This role is an onsite position requiring full‑time presence in classified manufacturing environments. Due to the hands‑on, real‑time nature of quality activities, this role is not eligible for remote or hybrid work.
- Provide QA review of moderate‑complexity manufacturing operations in classified environments.
- Maintain continuous on‑floor presence to support compliance, production activities, and issue resolution.
- Conduct complex in‑process batch record reviews and evaluate documentation for compliance and accuracy.
- Review manufacturing records, environmental monitoring data, and related documentation.
- Perform and verify line clearance activities for assigned...
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