Quality Assurance Associate

Role: Quality Associate supporting GMP manufacturing and documentation at Krystal Biotech's Astra facility. Responsibilities: ensure compliance with FDA and GxP standards, review and approve manufacturing and QC records, develop and update SOPs, oversee daily QA functions, and contribute to continuous improvement of quality systems. Requirements: Bachelor's in Biology or related field, 3+ years in biotech/pharma quality systems, strong knowledge of GMP, GLP, GCP, and FDA audit experience preferred. High-value: biologics/gene therapy manufacturing, cGXP documentation, regulatory compliance, audit readiness, and fast-paced environment. Work setup: not specified.