POSITION OVERVIEW

The Senior Specialist I, 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 Operation for Manufacturing logistics processes relating to Abeona Manufactured Media batch record review and release from start to end of manufacturing activities, in-process sampling / testing, autoclave, assay development, process development, and document management ensuring procedural and regulatory compliance throughout the manufacturing process. The Senior Specialist I, Quality Assurance will report to the Associate Manager, Quality Assurance or above and will support manufacturing and quality control as the production area Quality Assurance representative.

QUALIFICATIONS

• Minimum of a Bachelor’s degree in related field and/or equivalent experience.
• Minimum of 5 years of experience in quality and/or manufacturing in a pharmaceutical, biotech, or biologics cGMP regulated manufacturing environment preferred.
• Working knowledge of quality operations and ability to apply cGMPs in conformance to U.S. standards, and where appropriate, other regulatory authority standards.
• Working knowledge of GCP, GDP, GLP and cGMP regulations and their relevant ISO counterparts and ICH Guidelines
• Thorough knowledge of aseptic manufacturing processes.
• Excellent organizational skills, attention to detail, and Good Documentation Practices.
• Proficiency in MS Word, Excel, Power Point, Microsoft Office 365 and other applications.
• Ability to communicate and work independently with scientific and/or technical personnel.
• Must possess effective interpersonal, verbal, and writing skills, patience, professionalism, and the ability to effectively interact and communicate with internal staff and management.

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

• Process document control requests and issue-controlled forms, logbooks, notebooks, master production records, labels, and protocols.
• Reconcile issued controlled forms, logbooks, notebooks, master production records, and protocols.
• 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 site procedures, regulatory and cGMP guidelines.
• Compile and verify all batch-related documents into a final product lot disposition package.
• Communicate lot disposition pending issues to management.
• Review qualification / validation protocols and reports and ensure resolution of and discrepancies that occurred during execution.
• Control document lifecycle activities, including biennial review of procedures and document retention for select SOPs.
• Gather metric information for use in continuous improvement of areas of responsibility. Report to management as needed.
• Work with the Manufacturing, Quality Control, Assay Development, and Process Development departments 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.
• Support site inspections and inspection readiness activities.
• Enhance skills via regular training and continuing education, including professional society membership/participation.
• Completion of gowning qualification and maintaining status for entry into Aseptic processing area. Must be able to demonstrate a sound knowledge of aseptic gowning practices.
• Author, Approve or Authorize documents as assigned. Documents include but are not limited to: Master Production Records, Quality Control test methods/forms, Method Qualification/Validation records, Development Reports, etc. Authorization includes a review of the content for applicability in connection with customer audit/inspections as well as GMP compliance.
• Perform other duties as required.