Quality Assurance Associate

Role: Quality Associate supporting GMP manufacturing and documentation at a gene therapy biotech. Responsibilities: develop and review manufacturing documentation, ensure compliance with FDA regulations, oversee daily QA functions including records review and approval, update SOPs, and support site cGXP documentation. Requirements: Bachelor’s in Biology or related Life Science; 3+ years in biotech/pharma quality systems; strong GMP, GxP, and ICH knowledge; experience with FDA audits preferred. HighValue: gene therapy manufacturing, GMP compliance, FDA regulatory environment, documentation and audit support, fast-paced biotech setting. WorkSetup: onsite at Pittsburgh headquarters.