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UCLA Health is hiring: Quality Assurance Officer - HGCTF in Los Angeles County

UCLA Health, Los Angeles County, CA, United States


Description Under the supervision of the Director of the Human Gene and Cell Therapy Facility (HGCTF), the Quality Assurance Officer for the HGCTF is responsible for the day-to-day Good Manufacturing Practices (GMP) quality assurance compliance activities including document control. Annual Salary Range: $78500.00 – 163600.00 Qualifications All Required: Bachelor’s or Master’s degree in Biology, Chemistry, or related field with at least one year of GMP Quality Assurance experience; OR a PhD or PharmD with demonstrated knowledge of GMP Quality Assurance principles. Previous experience directly involved with federal regulations regarding GLP and GMP. Strong interpersonal communication skills to effectively and diplomatically interact with physicians, staff, administration sponsors Demonstrated skill in gathering pertinent data, preparing narrative reports, statistical reports, charts, graphs, and tables. Demonstrated ability to carry out analytical tasks, to identify and define issues and alternatives, to resolve problems, and to draw logical conclusions. Demonstrated skill in reviewing data and material compiled by others for completeness and accuracy to ensure that incorrect/incomplete data is corrected. Ability to deal with and maintain confidential and sensitive information with discretion. Ability to determine what information is confidential and to protect the confidentiality of that information. On occasion, ability to work flexible hours. Ability to attend off-site staff meetings, conferences and investigator meetings. Excellent English-writing skills to compose, proofread correspondence and written reports for conciseness, clarity, appropriate grammar, correct spelling, and proper punctuation. Ability to write concise and accurate administrative reports, policies, procedures, and correspondence. Working knowledge of some medical and scientific terminology for protocol abstracting and conversation with research personnel. Demonstrated skills with personal computers, spreadsheets, databases and word processing applications for the maintenance of administrative records, analysis of data, and the preparation of reports.Demonstrated skill in utilizing programs such as Word, Excel, and other database software. Ability to learn other systems/software as required. Demonstrated knowledge of FDA Good Laboratory Practice, Good Tissue Practice and Good Manufacturing Practice guidelines.

In Summary: The Quality Assurance Officer is responsible for the day-to-day Good Manufacturing Practices (GMP) quality assurance compliance activities including document control . The position requires a Bachelor's or Master’s degree in Biology, Chemistry, or related field with at least one year of GMP quality assurance experience .

En Español: Descripción Bajo la supervisión del Director de la Facilidad de Terapia Humana Genética y Celular (HGCTF), el Oficial de Garantía de Calidad para el HGCTF es responsable de las actividades diarias de cumplimiento de las Buenas Prácticas de Fabricación (GMP, por sus siglas en inglés) que incluyen el control de documentos. Rango Anual Salario: $78500.00 163600.00 Qualificaciones Todos requeridos: Licenciatura o Maestría en Biología, Química u otro campo relacionado con al menos un año de experiencia en GMP Assurance; O doctorado o farmacéutico con conocimiento comprobado de los principios de Garantia de calidad GMP. Experiencia previa directamente involucrada con las regulaciones federales GLP y GMP . Capacidad para asistir a reuniones de personal fuera del sitio, conferencias e encuentros de investigadores. Excelentes habilidades en inglés para componer, corregir correspondencia y informes escritos para la concisión, claridad, gramática apropiada, ortografía correcta y puntuación adecuada. Habilidad para escribir informes administrativos concisos y precisos, políticas, procedimientos y correspondencia. Conocimiento práctico de algunas terminologías médicas y científicas para el abstracto de protocolo y conversación con el personal de investigación.