Associate, Quality Assurance - Cleveland, United States - Abeona
Description
Position OverviewThe Specialist, Quality Assuranceperforms routine activities associated with manufacturing of cell and gene therapy products at the Abeona Therapeutics Inc.
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 Associate, Quality Assurance will report to the Supervisor, Quality Assurance or above and will support manufacturing as the production area Quality Assurance representative.
Essential Duties and ResponsibilitiesPosition is Day Shift with weekends (only as needed)Ensure all non-conformances are fully investigated and effective corrective/preventive actions (CAPA) are implemented in a timely manner.
Support 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 systemsReview and approve controlled documents including standard operating procedures, work instructions, validation protocols as assigned.
Assist in metric reporting and data analysis to help new processes or drive process improvement for quality systemsPerform internal inspections and walk-throughs of GMP areas.
Support site inspections and inspection readiness activities. Ensure the site is audit ready. Support data integrity efforts.Perform training for new and existing team members, prepares training materials as necessary.
Work closely with Manufacturing and Quality Control to Ensure that products are manufactured in compliance with site procedures, regulatory and cGMP guidelines.
Enhance skills via regular training and continuing education, including professional society membership/participation. Perform other duties as required.QualificationsMinimum 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.