Sr. Specialist - Trainer, Quality Assurance
About The Position
The Senior Specialist I Trainer, Quality Assurance, Quality Systems performs routine activities associated with manufacturing cell and gene therapy products at Abeona Therapeutics Inc.'s Cleveland, Ohio site. The position supports the maintenance and continuous improvement of quality systems for cGMP operations, including CAPA, quality events such as nonconformances and deviations, change control, training, document management, and regulatory compliance. The Senior Specialist serves as a key leader for the site GMP Training Program. This includes overseeing training systems, curriculum development, compliance metrics, and training effectiveness to ensure personnel are qualified and comply with regulatory and company requirements. The position may also support Document Control, CAPA, Deviations/Investigations, Change Control, or other Quality System functions. The general schedule is Monday through Friday, 9:00 a.m. to 5:00 p.m., with variable start and end times. Some late or weekend work may be required. With approval, the role offers work-from-home flexibility one day per week.
Requirements
- Bachelor's degree in Life Sciences, Computer Science, Engineering, or a related field; degrees in Education, Organizational Development, or a related field are also acceptable when combined with industry experience.
- 3–5+ years of experience in the biotechnology or pharmaceutical industry.
- Experience administering GMP training programs, Learning Management Systems, or training compliance programs.
- Experience developing training curricula, qualification matrices, training effectiveness measures, and employee development programs.
- Strong working knowledge of FDA regulations and data integrity principles.
- Excellent written and verbal communication skills.
- Strong organizational skills and the ability to manage multiple priorities in a fast-paced biotech environment.
Responsibilities
- Serve as the primary owner for one or more Quality Systems programs, leading the site Training Program and potentially supporting Document Control, CAPA, Deviations/Investigations, Change Control, or other Quality System functions.
- Lead and administer the site GMP Training Program in compliance with regulatory requirements, company procedures, and training standards.
- Develop, maintain, and continuously improve training curricula, qualification programs, and learning materials for GMP personnel.
- Coordinate onboarding, GMP orientation, role-based qualifications, annual retraining, and ongoing learning initiatives across functional areas.
- Administer the Training Management System, including assigning training and creating training plans, as applicable.
- Monitor training compliance metrics, identify gaps and overdue requirements, and work with department leaders to ensure timely completion.
- Evaluate training effectiveness using assessments, observations, performance metrics, and feedback, and implement improvements as needed.
- Maintain employee training records and ensure documentation is accurate, complete, and inspection-ready.
- Support and represent the Training function during internal audits, regulatory inspections, and customer audits.
- Partner with subject matter experts to develop, review, and update training content related to GMP operations, quality systems, and regulatory requirements.
Benefits
- Annual discretionary bonus
- Equity opportunities
- Robust health coverage options
- FSA/HSA options
- Company-paid basic dental and vision plans
- Lifestyle spending account with wellness reimbursements
- 401(k) retirement plan
- Up to 160 hours of paid time off accrual per calendar year, prorated based on date of hire
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What This Job Offers
Job Type
Full-time
Career Level
Senior
