Quality Assurance Associate

Role: Quality Associate supporting GMP manufacturing at Krystal Biotech, focusing on quality systems, documentation, and regulatory compliance. Responsibilities: develop and review GMP documentation, oversee review and approval of manufacturing and QC records, support SOP updates, and ensure compliance with FDA and cGXP standards. Requirements: Bachelor’s degree in Biology or related Life Science, 1+ years in biotech/pharma quality systems, knowledge of GMP/GLP/GCP preferred, familiarity with FDA environments advantageous. Skills: strong organizational, documentation, and communication abilities; proficient in MS Office; self-starter capable of multitasking in a fast-paced environment. HighValue: biotech/pharma quality systems, GMP manufacturing documentation, regulatory compliance, FDA environment experience. WorkSetup: based in Pittsburgh headquarters, no travel specified.