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Nicklaus Children’s Health System

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SPECIALIST-GXP QA - Regulatory Affairs
DescriptionExpected Starting Salary Range: 26.01 - 32.20SUBFUNCTION DEFINITION: Manufactures and tests cell in gene therapy products for internal and external phase I/II clinical trials.Development; technology transfer; scale up; manufacturing/processing/ and or testing; Qualifications and validations. Analyze data and assist others.REPRESENTATIVE RESPONSIBILITIESManufacturingmanufacturing/processing activities, process development, technology transfer, scale up, quality control, and high complexity analysis as directed following established SOPs and protocols. Complete accurate and detailed records and all documentation as required for compliance to GxP. Complete and maintain training required to perf


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