Quality Assurance Document Control Associate

Role: Quality Assurance Document Control Associate supporting implementation of document control systems within GMP manufacturing and QC lab at Krystal Biotech. Responsibilities: review, process, and distribute controlled documents (SOPs, protocols), manage document lifecycle, ensure compliance with cGMP and regulatory standards, maintain records retention, support audits and inspections, and coordinate batch activities. Requirements: Bachelor's degree preferred or equivalent experience; knowledge of FDA regulations and electronic record systems (Veeva QualityDocs preferred); highly organized, detail-oriented, able to handle sensitive documents, with strong communication and stakeholder management skills. High-Value: GMP manufacturing, quality systems, document control, FDA compliance, biotech/pharma regulations, support for investigational or commercial gene therapy products, based in Moon Township, PA.