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Technician II-GXP

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Cincinnati, United States Cincinnati Children's Hospital Medical Center Full time

SUBFUNCTION DEFINITION: Manufactures and tests cell in gene therapy products for internal and external phase I/II clinical trials. Regulated manufacturing processing; testing and other related tasks; analyze data; equipment maintenance; record-keeping. REPRESENTATIVE RESPONSIBILITIES · GMP Technician - Complete accurate and detailed records and all documentation as required for compliance to GxP. Complete and maintain training required to perform assigned tasks. Analyze data, perform statistical and graphical analysis of data, and interpret results. Maintain an active role in laboratory's meetings. · Operations - Perform maintenance and cleaning of the cleanroom manufacturing facility. Routinely perform the Environmental Monitoring sampling and/or testing of the sampled media. Support equipment calibration and validation. Complete accurate and detailed records. Complete and maintain training required to perform assigned tasks.Promptly respond to and troubleshoot erroneous results or problems with laboratory equipment or facilities. Order supplies from vendors and storeroom and ensure proper storage requirements are met. Report facility and equipment failure and alarms to laboratory management or QA team. · Compliance - Perform work with a high level of integrity and honesty.Practice a high level of integrity in maintaining confidentiality. Maintain required documentation systems.Willing and able to assist in daily operations of the laboratory including answering phone, organizing and cleaning of laboratory.Provides appropriate safety monitoring checks as assigned (radiation safety, biosafety, etc.) Perform other duties as assigned. · Process Improvement - Follow Standard Operating Procedures (SOP) and protocols.Cooperate with performance improvement initiatives and other compliance activities.Cooperate with Quality Assurance group to ensure the quality of product, test results and compliance.Perform assigned duties strictly according to SOP.Maintain required proficiency and competency requirements. · Training & Development - Assist in training laboratory personnel. May act as a mentor to more junior staff. Serve as the contact for resolution of complex issues, provide education, guidance and work direction. May provide input and feedback to managers on hiring decisions, professional development and performance management. Qualifications EDUCATION/EXPERIENCE Required: ·Bachelor's degree in a related field · 0 - 2 years of work experience in a related job discipline Preferred: Experience in a regulated environment (i.e. FDA, ISO, CAP, CLIA, FACT) cGMP experience in some or all of the following: -Good Documentation Practices -Material Receipt and Control -Cleanroom Operations and Controls -Laboratory Equipment Operation, Calibration, and Validation -Environmental Monitoring (i.e. Sampling and monitoring of viable and non-viable particulates) Cincinnati Children's is proud to be an Equal Opportunity Employer that values and treasures Diversity, Equity, and Inclusion. We are committed to creating an environment of dignity and respect for all our employees, patients, and families. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, genetic information, national origin, sexual orientation, gender identity, disability or protected veteran status. EEO/AA/M/F/Veteran/Disability Job Research Shift Day Job Job Type Standard Department 551007 - EH&CanBio - Translational Labs Employee Status Regular FTE 1.0 Weekly Hours 40 Salary Range 21.21-30.50