Position Overview

The Specialist I, Supplier Quality will perform routine activities associated with manufacturing of cell and gene therapy products at the Abeona Therapeutics Inc. site in Cleveland, OH.  This position supports the release of materials in support of cGMP Operations.  The Specialist I, Quality Assurance will report to the Supervisor, Quality Assurance or above.

Essential Duties and Responsibilities

Position is Day Shift with weekends (only as needed)

• Performs the following duties with minimal supervision.

• Adhere to GMP practices.

• Accurately review and approve controlled documents including suppliers Certificates of Analysis or Certificates of Conformity.

• Inspect incoming and manufactured materials for accuracy and defects.

• Work closely with other departments to release materials for GMP use.

• Maintain documentation in an organized manner both physically and electronically.

• Maintain a shared, organized workspace.

• Support change controls, as needed.

• Support site inspections, as needed.

• Work closely with functional groups to ensure processes and personnel remain in compliance with site procedures, regulatory and cGMP guidelines. 

• Perform other duties as required.

  Qualifications

• Minimum of a Bachelor’s degree in related field and/or equivalent experience. 

• Preferred at least 1 year of experience in quality and/or manufacturing in a pharmaceutical, biotech, or biologics cGMP regulated manufacturing environment preferred. 

• Working knowledge of systems and ability to apply cGMPs in conformance to U.S. standards, and where appropriate, other regulatory authority standards.

  Competencies

• Ability to work effectively and efficiently with minimal supervision.

• Possess basic problem-solving skills.

• 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.

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