The Quality Assurance Associate performs routine activities associated with manufacturing of cell and gene therapy products at the Abeona Therapeutics Inc. site in Cleveland, OH. Maintain the quality systems in support of a cGMP Operation for production processes relating to batch record review and release from start to end of manufacturing activities, primary and secondary packaging, label control, corrective and preventative actions, quality events management (e.g., nonconformances, deviations, etc.), training, document management, and regulatory compliance. The QA Associate will report to the Associate Director of Quality Assurance and will support manufacturing as the production area Quality Assurance representative.
Essential Duties and Responsibilities
Position is Day Shift with weekends (only as needed)
- Control document lifecycle activities, including biennial review of procedures and document retention.
- Process document control requests and issue controlled forms, logbooks, notebooks, master production records, and protocols.
- Work with the Manufacturing Department as a production area Quality Assurance representative. Key areas of collaboration include but are not limited to; calibration and preventive maintenance process monitoring and inventory control monitoring.
- Coordinate and facilitate QA-related production and production-related activities.
- Review batch-related documentation and ensure resolution of issues to release product.
- Ensure that products are manufactured in compliance with regulatory and GMP guidelines.
- Compile and verify all batch-related documents into a final product lot disposition package.
- Communicate lot disposition pending issues to management.
- Gather metric information for use in continuous improvement of areas of responsibility. Report to management as needed.
- Perform other duties as required.
- Bachelor’s degree in Biological Science or related field.
- Minimum of one (1) year quality and/or manufacturing experience in a pharmaceutical, biotech, or biologics GMP regulated manufacturing environment.
- Working knowledge of quality systems and ability to apply GMPs in conformance to U.S. standards, and where appropriate, other regulatory authority standards.
- Effective interpersonal, verbal, and written communication skills.
- General knowledge of aseptic manufacturing processes.
- Excellent organizational skills, attention to detail, and Good Documentation Practices.
- Proficiency in MS Word, Excel, Power Point, and other applications.
- Ability to communicate and work independently with scientific and/or technical personnel.
- Must possess effective communication 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 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.