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.

· Facilitate root cause analysis (RCA) using tools such as 5 Whys, Fishbone Diagrams, or other

structured approaches.

· Partner with Manufacturing, QC, Supply Chain, Facilities, Engineering, and other cross-functional

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

· Draft and track deviation reports, investigation summaries, CAPA, and Change Control records in

the eQMS.

· Ensure investigations and CAPAs meet regulatory expectations (e.g., FDA, EMA) and are

completed within required timelines.

· Perform trend analysis to identify recurring issues and drive continuous improvement.

· Collaborate closely with colleagues in Quality Assurance - Quality Systems department to ensure

timely opening and closing of quality records.

· Support inspection readiness activities, including presenting quality records during internal and

external audits.

· Contribute to the development and improvement of investigation-related SOPs and best practices.

· Support training and mentoring of operational staff on deviation reporting and investigation

processes.

· Support site inspections, as needed.

· Perform other duties as required.

Qualifications

· Minimum of a Bachelor's degree in Life Science, Engineering, or a related field and/or equivalent

experience.

· Minimum of 1-4 years of experience in quality and/or in a pharmaceutical, biotech, or biologics

cGMP regulated manufacturing environment preferred.

· Working knowledge of cGMPS, ICH Q9 (Quality Risk Management), FDA regulatory expectations.

· General knowledge of aseptic manufacturing processes.

· Strong technical writing skills with the ability to communicate complex issues clearly and concisely. · Proficient in electronic QMS tools (e.g., Veeva, MasterControl, TrackWise, etc.). · Collaborative team player with strong problem-solving skills and attention to detail.

Competencies

· 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 technical 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.

· Training or certification in investigation techniques (e.g., TapRoot, Kepner-Tregoe)

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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