At Krystal Biotech, Inc., the Quality Assurance Associate plays a pivotal role in upholding the highest standards of product quality within our pioneering gene therapy operations. Based in Pittsburgh, PA, this position supports our mission to deliver life-changing treatments by meticulously overseeing manufacturing processes that meet rigorous regulatory demands. Your work directly contributes to the safety and efficacy of therapies reaching patients worldwide. Daily responsibilities encompass conducting thorough batch record reviews for viral vector production, executing environmental monitoring protocols in cleanroom environments, and performing in-process inspections of bioreactor operations. Collaborate closely with manufacturing teams to investigate deviations using root cause analysis techniques like fishbone diagrams and CAPA implementation. You will audit supplier documentation for raw materials, ensure traceability in GMP documentation systems, and participate in validation activities for new equipment installations. Routine tasks include trend analysis of quality metrics and preparing reports for internal audits, fostering continuous improvement in our biotech production lines. A bachelor's degree in biology, chemistry, or a related life sciences field is required, along with at least 2 years of hands-on experience in a GMP-regulated pharmaceutical or biotech setting. Familiarity with FDA 21 CFR Part 211 regulations and ICH guidelines is essential. Proficiency in electronic quality management systems such as TrackWise or MasterControl, plus strong documentation skills, sets candidates apart. Success demands meticulous attention to detail, analytical prowess for data interpretation, and effective communication for cross-functional teamwork. Technical expertise in aseptic processing techniques and statistical process control complements soft skills like problem-solving under pressure and adaptability to evolving biotech protocols. Krystal Biotech cultivates a collaborative, innovation-driven culture in our state-of-the-art Pittsburgh facility, where small, agile teams tackle complex challenges. Employees thrive in a supportive environment that encourages professional growth through targeted training and project leadership opportunities. We offer a competitive compensation package including comprehensive health insurance, generous PTO, and 401(k) matching to support your well-being and long-term success.