Quality Assurance Specialist (Regulatory) CVPF(Center for Cellular Immunotherapy)
University of Pennsylvania

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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 TitleQuality Assurance Specialist (Regulatory) CVPF(Center for Cellular Immunotherapy)Job Profile TitleResearch Coordinator SeniorJob Description SummaryThe Quality Assurance Specialist will work within the Clinical Cell and Vaccine Production Facility (CVPF) for the review and release of investigational cell and gene therapy products for human administration manufactured at our facility.

This position is contingent upon funding.Job Description

Job Responsibilities

This position is a crucial component of the success of on-going clinical trials in immunotherapies. Main duties include:

• Review of manufacturing batch records and product release documentation under tight deadlines with impact on patients and clinical teams for early phase I/II first-in-human clinical development. Verify calculations, chain of custody, and all applicable records adhere to GDP, cGMP and applicable internal SOPs.

• Communicate errors and deviations identified during batch record review. Communicate effectively with cross functional teams to ensure on time delivery of QA review, errors are resolved and investigations are initiated and progressing in a timely manner

• Issue verified chain of custody labels and prepare release paperwork for human administration including Certificate of Analysis, shipping records for final infusible products.

• Conduct apheresis product receipt of fresh and frozen apheresis product collected and cryopreserved by CCI internal and external multi-center sites. Coordinate and follow-up with apheresis collection and cryopreservation site for addressing all observations during the receipt.

• Conduct verification of packaging, and releasing of final infusible product to administration sites.

• Anticipate potential roadblocks that may affect product release and alert management and cross functional teams within and outside of the Center for Cellular Immunotherapies, as applicable. Other Duties as assigned by management

• Closeout the EBR to ensure all applicable quality documents, assay reports for stability, sample transfer records, and external reports; and keeping the electronic PDF File up-to-date in the network SD.

• Assign, track, and maintain the Eternal Report, and CVPF Correspondences; and responsible for record retention prior to shipping offsite.

• Review other control quality documents such as SOPs, WIs, and guidance as needed.

• Assisting the QA Compliance group as needed to help with master batch record issuance and external audits, DFPs, CAPAs review.

• Assisting Manager as needed to help with raw materials release, new hire QA Associate train.

Position contingent upon funding.

Qualifications

• Bachelor of Science and 3 to 5 years of experience or equivalent combination of education and experience is required.

• Bachelor's degree in Biology or related science preferred. Master's degree preferred

• 3-5 years of experience in a GLP/GCP/GMP setting, or equivalent, with 1-3 years of direct experience in Quality
  role

• Excellent verbal and written communication skills and interpersonal skills

• Detail oriented and excellent organizational record keeping

• Knowledge of manufacturing biologics product required; and cell and gene therapy principles and technologies
  preferred.

• Flexibility to work with schedule changes

• Working knowledge of FACT Common Standards for Cellular Therapy preferred

Job Location - City, StatePhiladelphia, PennsylvaniaDepartment / SchoolPerelman School of MedicinePay Range$43,919.00 - $85,000.00 Annual RateSalary 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 grade profile. Affirmative Action Statement
Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.Special Requirements
Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.University Benefits

• Health, Life, and Flexible Spending Accounts: Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family's health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.
• Tuition: Take advantage of Penn's exceptional tuition benefits. You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions.
• Retirement: Penn offers generous retirement plans to help you save for your future. Penn's Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis. Choose from a wide variety of investment options through TIAA and Vanguard.
• Time Away from Work: Penn provides you with a substantial amount of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with family-whatever your personal needs may be.
• Long-Term Care Insurance: In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility. If you apply when you're newly hired, you won't have to provide proof of good health or be subject to underwriting requirements. Eligible family members must always provide proof of good health and are subject to underwriting.
• Wellness and Work-life Resources: Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life. That's why we offer a wide variety of programs and resources to help you care for your health, your family, and your work-life balance.
• Professional and Personal Development: Penn provides an array of resources to help you advance yourself personally and professionally.
• University Resources: As a member of the Penn community, you have access to a wide range of University resources as well as cultural and recreational activities. Take advantage of the University's libraries and athletic facilities, or visit our arboretum and art galleries. There's always something going on at Penn, whether it's a new exhibit at the Penn Museum, the latest music or theater presentation at the Annenberg Center, or the Penn Relays at Franklin Field to name just a few examples. As a member of the Penn community, you're right in the middle of the excitement-and you and your family can enjoy many of these activities for free.
• Discounts and Special Services: From arts and entertainment to transportation and mortgages, you'll find great deals for University faculty and staff. Not only do Penn arts and cultural centers and museums offer free and discounted admission and memberships to faculty and staff. You can also enjoy substantial savings on other goods and services such as new cars from Ford and General Motors, cellular phone service plans, movie tickets, and admission to theme parks.
• Flexible Work Hours: Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments. These approaches involve use of non-traditional work hours, locations, and/or job structures.
• Penn Home Ownership Services: Penn offers a forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia, which can be used for closing costs or home improvements.
• Adoption Assistance: Penn will reimburse eligible employees on qualified expenses in connection with the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions in your household.

To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay

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