| Position Overview |
| The Specialist II, 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 Operations, corrective and preventative actions, quality events management (e.g., nonconformances, deviations, etc.), training, document management and ensuring procedural and regulatory compliance throughout the manufacturing process. The Specialist II, Quality Assurance will report to the Supervisor, Quality Assurance or above. |
| Essential Duties and Responsibilities |
Position is Second Shift (2:00PM – 10:00PM) with occasional weekends (as needed)
- Review and ensure all non-conformances are fully investigated and ensure effective corrective/preventive actions (CAPA) are implemented in a timely manner.
- Leads change management processes including formal change controls by evaluating the proposed changes, assessing impact, and providing quality input on implementation plans.
- Write new standard operating procedures or revise existing documentation utilizing document management systems.
- Control document lifecycle activities, including biennial review of procedures and document retention for select SOPs.
- Develop and present metric reporting and data analysis to help new processes or drive process improvement for quality systems.
- Perform training for new and existing team members, prepare training materials as necessary.
- Support site inspections and inspection readiness activities.
- Participate in internal audits of functional areas.
- Lead one the following: Document Control, CAPA, Deviations/Investigations, Change Controls, Training, or other key functions.
- Work closely with functional groups to ensure processes and personnel remain in compliance with site procedures, regulatory and cGMP guidelines.
- Prioritize Quality Assurance workload as needed/priorities shift.
- Enhance skills via regular training and continuing education, including professional society membership/participation.
- Perform other duties as required.
|
| Qualifications |
- Minimum of a Bachelor’s degree in related field and/or equivalent experience.
- Minimum of 3 years of experience in quality and/or manufacturing in a pharmaceutical, biotech, or biologics cGMP regulated manufacturing environment preferred.
- Working knowledge of quality systems and ability to apply cGMPs in conformance to U.S. standards, and where appropriate, other regulatory authority standards.
- General knowledge of aseptic manufacturing processes.
|
| 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 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.
|
| Working Accommodations |
This is a flexible work role. This position is eligible to work remotely on a periodic basis based on site
needs. The position has flexibility in conducting some work activities remotely while also having work that requires him/her to be at the office on a regular basis. All days working remotely require manager approval. |
| 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. |
