Quality Assurance Specialist 2, Batch Release Contractor
ProKidney, 3929 Westpoint Blvd, Suite G, Winston-Salem, NC 2710 +1
The role
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.