Sr. Specialist I, Quality Assurance - Quality Operations

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.

Position Overview

The Senior 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, assay development, process development, and document management ensuring procedural and regulatory compliance throughout the manufacturing process. The Senior 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.

Essential Duties and Responsibilities

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.
• Review qualification / validation protocols and reports and ensure resolution of and discrepancies that occurred during execution.
• Control document lifecycle activities, including biennial review of procedures and document retention for select SOPs.
• Gather metric information for use in continuous improvement of areas of responsibility. Report to management as needed.
• Work with the Manufacturing, Quality Control, Assay Development, and Process Development departments 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, Method Qualification / Validation records, Development Reports, 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.

Qualifications

Competencies

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to experience prolonged sitting, some bending, stooping, and stretching. Hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required. A normal range of hearing and vision correctable to 20 / 20 is required. Occasional lifting up to 20 pounds is required.

Benefits

Our values apply to how we view caring for each other as well. While the patient comes first, our employees are vital to making that happen, and so we strive to offer a competitive benefits package that includes :

Visa Sponsorship Not Currently Available

IMPORTANT : Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Visa Sponsorship Not Currently Available

IMPORTANT : Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.