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QA Analyst, GMP Doc Control (CVPF)(Center for Cellular Immunotherapy)
University of Pennsylvania
QA Analyst, GMP Doc Control (CVPF)(Center for Cellular Immunotherapy)
University of Pennsylvania
 QA Analyst, GMP Doc Control (CVPF)(Center for Cellular Immunotherapy) University Overview The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn's distinctive interdisciplinary approach to scholarship and learning. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America's Best Large Employers in 2023. Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play. The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more. Posted Job Title QA Analyst, GMP Doc Control (CVPF)(Center for Cellular Immunotherapy) Job Profile Title Research Coordinator Job Description Summary Reporting to the Quality Assurance Manager, the Quality Assurance Analyst, GMP Doc Control plays a critical role in supporting the quality operations of the Clinical Cell and Vaccine Production Facility (CVPF) for the aseptic manufacture of novel cell and gene therapies. The QA Analyst, Doc Control will primarily be responsible for managing the CVPF's document management system (Veeva QualityDocs), updating and issuing batch records, and maintaining the training program (Veeva Learning Management System (LMS)). This role is pivotal as it works closely with the Clinical Operations team to ensure batch records are released as quickly as possible once enrolled patients are confirmed for upcoming manufacturing slots. The QA Analyst, GMP Doc Control also ensures all CVPF staff are fully trained in the most current procedures to guarantee all cell therapy products are manufactured to the highest quality and regulatory standards. In addition to these responsibilities, the incumbent will also assist the rest of the QA team in management and improvement of the QMS. The CVPF is accredited by the Foundation for the Accreditation of Cellular Therapies (FACT) which includes an on-site inspection every 3 years and annual renewal applications. The CVPF also supports external biotech companies as a Contract Manufacturing Organization (CMO) who periodically audit the CVPF for compliance with cGMPs and contracted terms. The QA Analyst, GMP Doc Control will play a pivotal role in these activities. Job Description Job Responsibilities
Qualifications
Preferred Qualifications:
Job Location - City, State Philadelphia, Pennsylvania Department / School Perelman School of Medicine Pay Range $43,888.00 - $65,000.00 Annual Rate Salary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, as well as internal and market factors and the pay range assigned to the job profile. Equal Opportunity Statement The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics), citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law. Special Requirements Background checks may be required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job. University Benefits
To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay To apply, visit https://wd1.myworkdaysite.com/en-US/recruiting/upenn/careers-at-penn/job/Smilow-Center-for-Translational/QA-Analyst--GMP-Doc-Control--CVPF--Center-for-Cellular-Immunotherapy-_JR00103627-1 Copyright 2024 Jobelephant.com Inc. All rights reserved. Posted by the FREE value-added recruitment advertising agency jeid-252513b3276eda4685b4205c41e6585c
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Internal Number: 6035323
About University of Pennsylvania
Penn has a long and proud tradition of intellectual rigor and pursuit of innovative knowledge, begun by Benjamin Franklin in 1740. That tradition lives today through the creativity, entrepreneurship, and engagement of our faculty, students, and staff. Academic life at Penn is unparalleled, with an undergraduate student body of 10,000 from every U.S. state and around the world. The entering class of 2015 is the most talented and diverse in Penn's history. Consistently ranked among the top 10 universities in the country, Penn welcomes an additional 10,000 students to our top-ranked graduate and professional schools.
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