Quality Assurance Specialist

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:,ActualValueFromSolar:null},{QuestionName:Job Summary,AnswerValue:JOB OVERVIEWu003cbr/u003eThe Quality Assurance Specialist will, with the guidance of the program manager and program faculty, perform quality assurance activities for the UCSF Cellular Therapy Development Laboratory and the UCSF Human Islet and Cellular Transplantation Facility (HICTF) and GMP Facility. These laboratories support a wide range of experimental cellular therapy development and manufacturing activities focusing on regulatory T cells, anti-cancer T cell therapy, CRISPR-Cas9-modified T cell therapies, and human stem cell-based therapies. The focus of the group is on first-in-human phase 1 clinical trials. We do not perform standard of care cellular therapy activities, such as hematopoetic stem cell transplants, which are handled by other UCSF facilities. u003cbr/u003eu003cbr/u003eYou will work with academic groups at all stages of the cellular therapy development and manufacturing process and with partners and clients in the biopharmaceutical industry who have collaborations or manufacturing activities ongoing with our group. You will work in close collaboration with the regulatory affairs, manufacturing, operations, and QC groups.u003cbr/u003eu003cbr/u003eu003cbu003e**This position may be eligible for a permanent remote work agreement if the candidate has appropriate experience and is available for video-based meetings.u003c/bu003eu003cbr/u003eu003cbr/u003eDIABETES CENTER u003cbr/u003eThe UC San Francisco Diabetes Center is a comprehensive research and treatment facility with a broad focus on clinical care, education and both basic and clinical research. The Center maintains a multidisciplinary and highly collaborative environment that brings together expertise from the UCSF Departments of Medicine, Surgery, Pediatrics, Microbiology u0026 Immunology and others.u003cbr/u003eu003cbr/u003eABOUT UCSF u003cbr/u003eThe University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It is the only campus in the 10-campus UC system dedicated exclusively to the health sciences.u003cbr/u003eu003cbr/u003e*LI-AH1,VerityZone:jobdescription,QuestionType:textarea,ActualValueFromSolar:null},{QuestionName:Organization,AnswerValue:Campus,VerityZone:location,QuestionType:select,ActualValueFromSolar:null},{QuestionName:Req Number,AnswerValue:55849BR,VerityZone:autoreq,QuestionType:text,ActualValueFromSolar:null},{QuestionName:Location,AnswerValue:Remote,VerityZone:formtext8,QuestionType:single-select,ActualValueFromSolar:null},{QuestionName:Job Title,AnswerValue:Quality Assurance Specialist,VerityZone:formtext10,QuestionType:text,ActualValueFromSolar:null},{QuestionName:Appointment Type,AnswerValue:Career,VerityZone:formtext12,QuestionType:radio,ActualValueFromSolar:null},{QuestionName:Percentage,AnswerValue:100%,VerityZone:formtext13,QuestionType:Text,ActualValueFromSolar:null},{QuestionName:Shift Length,AnswerValue:8 Hours ,VerityZone:formtext14,QuestionType:Radio,ActualValueFromSolar:null},{QuestionName:Shift,AnswerValue:Days,VerityZone:formtext15,QuestionType:Checkbox,ActualValueFromSolar:null},{QuestionName:Work Days,AnswerValue:Monday - Friday, 9:00 am - 5:00 pm and as necessary,VerityZone:formtext16,QuestionType:Text,ActualValueFromSolar:null},{QuestionName:Required Qualifications,AnswerValue:• Bacheloru0027s degree in related area and/or equivalent experience/trainingu003cbru003e• Minimum three years of experience in healthcare, biotech, or pharma QAu003cbru003e• Thorough knowledge of regulations governing HCT/Ps, including: cGMP, cGTP, and GLPu003cbru003e• Thorough knowledge of QA best practices, tools, and techniquesu003cbru003e• Detail oriented, with proven ability to effectively manage time, see projects through to completion, organize competing priorities, and effectively address complex, urgent issues as they ariseu003cbru003e• Strong skills required to effectively convey complex clinical and technical information both verbally and in writing and to produce high quality reports and documentationu003cbru003e• Strong critical thinking and problem solving skills to manage multiple levels of information and responsibilities, to quickly assess complex problems, and to develop and implement timely and effective solutionsu003cbru003e• Strong interpersonal skills for collaborating effectively with a broad range of clinical and technical staff and representatives of external regulatory agencies and for mentoring lower-level QA staff,VerityZone:formtext3,QuestionType:textarea,ActualValueFromSolar:null},{QuestionName:Preferred Qualifications,AnswerValue:• At least five years of experience in healthcare, biotech, or pharma QA or equivalentu003cbru003e• Strong knowledge of various administrative and business software packages, and of the specialized applications for quality data managementu003cbru003e• Strong skills to influence staff, management, and clinicians at all levels and across departments,VerityZone:formtext4,QuestionType:textarea,ActualValueFromSolar:null},{QuestionName:License/Certification,AnswerValue:n/a,VerityZone:formtext5,QuestionType:textarea,ActualValueFromSolar:null},{QuestionName:Position Type,AnswerValue:Full Time,VerityZone:formtext6,QuestionType:radio,ActualValueFromSolar:null},{QuestionName:Department Name,AnswerValue:Diabetes Center,VerityZone:formtext17,QuestionType:text,ActualValueFromSolar:null},{QuestionName:Equal Employment Opportunity,AnswerValue:The University of California San Francisco is an Equal Opportunity/Affirmative Action Employer. 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