Abeona Therapeutics, a leader in gene therapy development, seeks a Specialist I, Quality Assurance - Quality Operations to safeguard the integrity of our innovative biopharmaceutical manufacturing processes in Cleveland, OH. This position plays a pivotal role in upholding current Good Manufacturing Practices (cGMP) across our state-of-the-art facility, where we pioneer adeno-associated virus (AAV) vectors for rare diseases. Your meticulous oversight will directly contribute to the safe delivery of life-changing therapies to patients worldwide. Day-to-day, you will conduct thorough batch record reviews for clinical and commercial products, scrutinizing documentation for adherence to approved procedures. Expect to lead root cause analyses for quality deviations using structured tools like fishbone diagrams and 5-Why methodology, collaborating with Manufacturing, MS&T, and Supply Chain teams to implement corrective and preventive actions (CAPAs). You will perform internal audits targeting high-risk areas such as aseptic processing and raw material qualification, while preparing detailed reports for management review. Participation in cross-functional projects, including validation of new equipment and process changes, ensures seamless integration of quality into every stage of operations. Routine interactions with contract manufacturing organizations (CMOs) involve reviewing their quality systems and resolving discrepancies to maintain supply chain reliability. 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 biopharma quality assurance or operations. Familiarity with FDA regulations, 21 CFR Part 211, and ICH guidelines is essential, as is proficiency in electronic quality management systems (eQMS) like TrackWise or MasterControl. Prior exposure to cell and gene therapy manufacturing processes strengthens candidacy. Technical acumen in statistical process control and risk-based auditing pairs with strong analytical thinking and attention to detail. Effective communication skills enable clear articulation of complex findings to diverse stakeholders, while a proactive mindset drives continuous improvement in a fast-paced biotech setting. Our Cleveland team fosters a collaborative, science-centric culture emphasizing innovation and employee development. Work alongside experts in a modern facility equipped for advanced bioprocessing, with ample opportunities for career progression in quality leadership. We provide a competitive compensation package that includes comprehensive health insurance, generous PTO, and 401(k) matching.