Specialist , Quality Assurance, Supplier Quality

Overview

About Abeona

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

This Specialist I, Quality Assurance, Supplier Quality role will perform routine activities associated with manufacturing of cell and gene therapy products at the Abeona Therapeutics Inc. site in Cleveland, OH. This on-site position supports the release of incoming materials in support of cGMP Operations. The Specialist I, Quality Assurance, Supplier Quality, will report to the Associate Manager, Quality Assurance - Supplier Quality or above.

This is an early career position that provides a great entry into a career in Quality!

This position is currently five days per week on day shift (occasional weekends as needed), with the potential to change to four, ten-hour shifts in the future (schedules are subject to change based on company need).

• Performs the following duties with minimal supervision.
• Adhere to GMP practices.
• Accurately review and approve controlled documents including suppliers Certificates of Analysis or Certificates of Conformity.
• Inspect incoming materials and Abeona Manufactured Materials for accuracy and defects.
• Work closely with other departments to release materials for GMP use.
• Maintain documentation in an organized manner both physically and electronically.
• Maintain a shared, organized workspace.
• Support change controls, as needed.
• Support site inspections, as needed.
• Work closely with functional groups to ensure processes and personnel remain in compliance with site procedures, regulatory and cGMP guidelines.
• 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 preferred.
• Working knowledge of systems and ability to apply cGMPs in conformance to U.S. standards, and where appropriate, other regulatory authority standards.

Other Competencies

• Ability to work effectively and efficiently with minimal supervision.
• Possess basic problem-solving skills.
• Excellent organizational skills, attention to detail, and Good Documentation Practices.
• Proficiency in MS Word, Excel, Power Point, Microsoft Office 365 and other applications.
• Must possess effective interpersonal, verbal, and writing skills, patience, professionalism, and the ability to effectively interact and communicate with internal staff and management.
• Comfortable in a fast-paced, patient-focused manufacturing environment with minimal direction and able to adjust workload based on changing priorities.

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 accommodation 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…