SPECIALIST I, QUALITY ASSURANCE – INVESTIGATIONS AND QUALITY RECORDS MANAGEMENT

Position Overview

The Specialist I, Quality Assurance supports the electronic management of entries in the Enterprise

Quality Management System (EQMS), to support Good Manufacturing Practices (GMP) compliance at

the Abeona Therapeutics Inc. site in Cleveland, OH. This role will be responsible for leading, writing,

and managing quality investigations related to deviations, non-conformances, out-of-specification

(OOS) results, CAPAs, and Change Controls within a GMP-regulated cell and gene therapy

manufacturing environment. The ideal candidate will bring experience in root cause analysis, strong

scientific acumen, and an ability to work cross-functionally to ensure timely, compliant, and effective

resolution of quality issues.

This role serves as an embedded quality assurance representative within various GMP

departments / functional groups.

Essential Duties and Responsibilities

Position is Day Shift with occasional weekends (as needed).

• Performs the following duties with minimal supervision.
• Work within Abeona's Enterprise Quality Management System (eQMS) to lead and author

thorough, timely, and compliant investigations into deviations, laboratory OOS / OOT results,

environmental monitoring excursions, and other quality events.

structured approaches.

teams to gather data, assess impact, and determine corrective and preventive actions (CAPAs).

the eQMS.

completed within required timelines.

timely opening and closing of quality records.

external audits.

processes.

Qualifications

experience.

cGMP regulated manufacturing environment preferred.

Competencies

and the ability to effectively interact and communicate with internal staff and management.

able to adjust workload based on changing priorities.

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.

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