Quality Assurance Associate

Krystal Biotech, Inc. is seeking a highly motivated and experienced Quality Associate to support quality systems, GMP manufacturing processes and documentation practices at our headquarters in Pittsburgh's South Side. Primary Responsibilities: * Work with internal teams to obtain an understanding of the product and the documentation requirements. * Produce high-quality documentation that meets applicable standards and is appropriate for its intended use. * Develop expertise on FDA regulations and audit processes. * Initiate and update GMP manufacturing associated documentation, such as clearing procedures. * Provide oversight of daily QA functions which include review and approval of records generated by manufacturing and quality control documents. * Provide support for updates on standard operating procedures and associated forms. * Assist with QA efforts for site cGXP documentation related to the operation of gene therapy manufacturing. * Ensure compliance with regulatory agencies and oversee continuous improvement of company's QA and compliance functions. Requirements & Desired Competencies: * Minimum of a Bachelor’s Degree (Biology or related Life Science) with 3+ years of relevant quality systems experience in the biotech or pharmaceutical industry. * Background that includes knowledge/experience in GMP, GLP, and GCP. * Experience with FDA audits is highly preferred. * Strong knowledge of GMP and ICH requirements. * Must be a self-starter and capable of working with minimal oversight. * Must be able to handle multiple roles and work in a fast paced and changing environment and know how to prioritize activities appropriately. * Excellent oral and written communication skills.