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Provide qualification and validation support for manufacturing processes, equipment/instrumentation, facilities, laboratory methodology and quality assurance procedures that are essential to the GxP production and analysis of biomedical products or CAP/CLIA requirements for high complexity analysis. Manufacturing- manufacturing/processing activities, process development, technology transfer, scale up, quality control, and high complexity analysis as directed following established SOPs and protocols.

HOUR

Cincinnati Children's Hospital Medical Center

GXP Specialist or Technician I/II - Applied Gene & Cell Therapy Center

The BMET II position serves as the primary point of contact and acts as a liaison between the TCH Enterprise and the manufacturer; shall assist with quality problems, as well as the resolution and escalation of technical or clinical issues; and ensures preventive maintenance/repairs are performed in accordance with the manufacturer guidelines and requirement for accreditation. Performs or ensures preventative maintenance, QA, and functional inspections are performed in accordance with the manufacturer guidelines and requirements and documents in accordance with clinical engineering medical equipment management program to meet Joint Commission, CMS, or other regulatory or accreditation agencies.

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