Specialist , Quality Assurance - Quality Operations

Specialist I, Quality Assurance - Quality Operations

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Our Values:
Patient First | Innovation | Integrity | Determination | Trust

Join us in making cure the new standard of care. At Abeona Therapeutics, we exist for our patients and their caregivers; their needs guide our decision‑making. We challenge ourselves to think differently, move quickly, and deliver solutions. We hold ourselves to the highest ethical and quality standards. We persevere with resilience and focus to achieve our mission. We build trust through humility, mutual appreciation, openness, and respect.

Company Description

Abeona Therapeutics Inc. is a commercial‑stage biopharmaceutical company focused on developing cell and gene therapies for serious diseases. Notably, Abeona's ZEVASKYN™ (prademagene zamikeracel) is the first autologous cell‑based gene therapy treating wounds in adults and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). The company's cGMP manufacturing facility in Cleveland, Ohio, is dedicated to producing ZEVASKYN™. Abeona's portfolio includes adeno‑associated virus (AAV)-based gene therapies for ophthalmic diseases with unmet medical needs, and their novel AAV capsids aim to improve treatment outcomes for various debilitating conditions.

The Specialist I, Quality Assurance performs routine activities associated with manufacturing of cell and gene therapy products at the Abeona Therapeutics Inc. site in Cleveland, OH. This position supports the maintenance of the quality systems in support of a cGMP Operation for Manufacturing logistics processes relating to Abeona Manufactured Media batch record review and release from start to end of manufacturing activities, in‑process sampling / testing, autoclave, and document management ensuring procedural and regulatory compliance throughout the manufacturing process.

The Specialist I, Quality Assurance will report to the Associate Manager, Quality Assurance or above and will support manufacturing and quality control as the production area Quality Assurance representative.

• Position is on a Day Shift with occasional weekends (as needed).
• Process document control requests and issue‑controlled forms, logbooks, notebooks, master production records, labels, and protocols.
• Reconcile issued controlled forms, logbooks, notebooks, master production records, and protocols.
• Coordinate and facilitate QA‑related production and production‑related activities.
• Review batch‑related documentation and ensure resolution of issues to release product.
• Ensure that products are manufactured in compliance with site procedures, regulatory and cGMP guidelines.
• Compile and verify all batch‑related documents into a final product lot disposition package.
• Communicate lot disposition pending issues to management.
• Gather metric information for use in continuous improvement of areas of responsibility. Report to management as needed.
• Work with Manufacturing and Quality Control as a production area Quality Assurance representative. Key areas of collaboration include but are not limited to; calibration and preventive maintenance, process monitoring, and inventory control monitoring.
• Support site inspections and inspection readiness activities.
• Enhance skills via regular training and continuing education, including professional society membership/participation.
• Completion of gowning qualification and maintaining status for entry into Aseptic processing area. Must be able to demonstrate a sound knowledge of aseptic gowning practices.
• Author, Approve or Authorize documents as assigned. Documents include but are not limited to:
  Master Production Records, Quality Control test methods/forms, etc. Authorization includes a review of the content for applicability in connection with customer audit/inspections as well as GMP compliance.
• Perform other duties as required.

• Minimum of a Bachelor's degree in related field and/or equivalent experience.
• Minimum of 1 year of experience in quality and/or manufacturing in a pharmaceutical, biotech, or biologics cGMP regulated manufacturing environment…