Specialist GXP-QA - Applied Gene & Cell Therapy Center
Cincinnati Children's · US
JOB RESPONSIBILITIES - Quality Assurance- Implements defined document control activities. Performs product release activities with oversight as needed.
Job description
JOB RESPONSIBILITIES: Quality Assurance- Implements defined document control activities. Performs product release activities with oversight as needed. Review and approve official documents, such as but not limited to executed batch records, validation protocols, deviations, standard operating procedures, deviations, etc. related to the quality management system. Supports the conduct of internal and external audits, including vendor qualification audits, with direction. Participate in risk assessments related to manufacturing and testing activities, with direction, and document outcomes. Interacts with manufacturing/operations personnel as needed, including minimal interaction with external stakeholders. Identifies the need for quality improvement activities and works under the direction of more senior personnel to achieve desired outcomes. Regulatory Knowledge & Oversight- With limited direction from more senior QA staff and within a clearly defined scope, applies specific elements of federal and state law and institutional policies/procedures/guidance to ensure that all aspects of manufactured products, regulatory submissions (e.g. Drug Master File) and operational procedures are...