QA Jobs in Cary, NC

Provides external quality assurance oversight for CDMOs and analytical laboratories supporting clinical and commercial gene therapy supplies. Reviews GMP documentation, batch records, specifications, testing protocols, deviations, CAPAs, and change controls. Authors quality procedures, monitors quality metrics, guides cross-functional compliance decisions, manages suppliers, and supports audits, regulatory inspections, technology transfers, and commercial readiness.

Lead site QA for GMP/GDP manufacturing and distribution, overseeing quality operations, deviations, CAPAs, inspections, secondary packaging, warehouse controls, and a QA team. Drive QMS improvements, regulatory compliance, risk-based decisions, and cross-functional stakeholder engagement to protect patient safety and product quality.

Lead Site Quality Assurance for a clinical manufacturing facility, overseeing CGMP compliance, quality operations, batch disposition, investigations, CAPA, change control, validation, regulatory inspections, supply chain quality, environmental monitoring, and data integrity. Build and mentor the local QA team, provide quality oversight for AAV and gene therapy manufacturing, support regulatory filings, and drive risk-based decisions and continuous improvement.

The QA Tester will be responsible for writing test cases, understanding testing methodologies, and documenting bugs. Familiarity with various operating systems and web technologies is essential.

Provide on‑floor QA oversight for aseptic cell‑based manufacturing, review batch records and logbooks, support investigations and CAPA, verify maintenance/calibration records, ensure isolator/BSC and cleanroom compliance, support regulatory inspection readiness, and maintain Quality Management System processes (Deviations, Change Control, CAPA, Document Management).

Lead feature-level test planning and execution for Fortnite Reload/Arenas. Perform functional, performance, and exploratory testing; manage and triage defects; communicate risks and test gaps to stakeholders; improve QA processes and troubleshoot hardware or system issues to unblock testing.