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

• Assist QA Specialists with the day-to-day operation of the Document Control System and training program.
• Update master batch records and issue all requested production copies as requested by QA Specialists.
• Developing expert knowledge of document management and training systems.
• Assisting QA specialists with document revision processes and periodic review of documents.
• Assisting QA specialists with the CVPF training program.
• Review any procedures related to this subject matter area.
• Maintain employee training binders.
• Send and retrieve documents from off-site storage as requested by QA specialists and other functional groups.
• Compile training metrics.
• Support regulatory and client inspections.
• Mediate any lack of document management efficiency or effectiveness.

Qualifications

• Bachelor’s degree with at least 1-3 years of related experience in document control and/or training coordination.
• Previous working experience in a GMP/GLP environment is required.
• Experience with a digital QMS such as Veeva, Title 21, or equivalent.
• Able to meet deadlines on short notice due to changes in patient status/enrollment

Preferred Qualifications:

• Knowledge in cell and gene therapy
• Working knowledge of FACT Common Standards for Cellular Therapy, 21 CFR 210 & 211, and ICH Guidelines

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

$44,500.00 - $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, and in alignment with salary ranges based on external market data for the job’s level. Internal organization and peer data at Penn are also considered.

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

• 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.

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