- 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 the release paperwork 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
- Assign, and maintain the Eternal Report, and CVPF Correspondences.
-Review other control quality documents such as SOPs, WIs, and guidance as needed.
QQUALIFICATIONS:- Bachelor's degree in Biology or related science
- 1-3 years of experience in a GLP/GCP/GMP setting, or equivalent, with >1 year of direct experience in Quality role
- Excellent verbal and written communication skills and interpersonal skills
- Detail oriented, and Excellent organizational record keeping
- Flexibility to work with schedule changes
- Knowledge of manufacturing biologics product and cell and gene therapy principles and technologies preferred.
- Working knowledge of FACT Common Standards for Cellular Therapy preferred
This position is contingent upon grant funding.
Job Location - City, State
Philadelphia, Pennsylvania
Department / School
Perelman School of Medicine
Pay Range
$37, $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 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:
To apply, visit
Copyright 2022 Inc. All rights reserved.
Posted by the FREE value-added recruitment advertising agency
jeid-6aed03ff2c6b8c498ee4459cf1ef720a - Bachelor's degree in Biology or related science
-
Quality Assurance Analyst
6 days ago
Trustees of University of Pennsylvania Philadelphia, United States Full timeDescription · 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 app ...
-
Quality Assurance Analyst
3 weeks ago
University of Pennsylvania Philadelphia, United StatesUniversity 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 ...
-
Quality Assurance Analyst
3 weeks ago
University of Pennsylvania Philadelphia, PA, United StatesUniversity 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.News & World Repo ...
-
Quality Assurance Analyst
3 weeks ago
IT Excel LLC Philadelphia, United States Full timeJob Description -The QA analysis job description encompasses two main roles testing and documentation. After software developers complete software programming quality assurance analysts test it. They use a variety of tools testing applications and reports to compare the software ...
-
Junior Quality Assurance Analyst
15 hours ago
TRESUME Philadelphia, United States**Job Title**: Junior Quality Assurance Analyst · **Job Summary**: · **Responsibilities**: · - Create, execute, and maintain test cases and test scripts based on product requirements and design documents. · - Identify, document, and report software defects and issues using tracki ...
-
Data Warehouse Quality Assurance Analyst
1 week ago
Philadelphia Streets Philadelphia, United States**Data Warehouse Quality Assurance Analyst** · 1601 Market St, Philadelphia, PA 19102, USA · Full-time · **Company Description** · Who We Are · A best-in-class city that attracts best-in-class talent, Philadelphia is an incredible place to build a career. From our thriving a ...
-
Quality Assurance Analyst
2 weeks ago
Tyndale Company, Inc. Doylestown, United StatesOverview · The Tyndale Company, a private, 7x Top Workplace winner and industry leading national supplier of arc-rated flame resistant (FR) clothing to the utilities, oil and gas, transportation, chemical manufacturing, molten metals, and NFPA 70E markets. We're a family-owned, a ...
-
Quality Assurance Analyst
1 week ago
YCS Somerdale, United StatesYouth Consultation Service (YCS) is a behavioral health and social services agency that has been caring for at risk children and families since 1918 in therapeutic residences, special education schools, in-home and in-community programs throughout NJ.Currently seeking a Quality A ...
-
Quality Assurance Analyst
1 week ago
YCS Somerdale, United StatesYouth Consultation Service (YCS) is a behavioral health and social services agency that has been caring for at risk children and families since 1918 in therapeutic residences, special education schools, in-home and in-community programs throughout NJ. · Currently seeking a Quali ...
-
Quality Assurance Analyst
2 weeks ago
Tyndale Company, Inc. Doylestown, United StatesOverview · The Tyndale Company, a private, 7x Top Workplace winner and industry leading national supplier of arc-rated flame resistant (FR) clothing to the utilities, oil and gas, transportation, chemical manufacturing, molten metals, and NFPA 70E markets. We're a family-owned, a ...
-
Quality Assurance Analyst
2 days ago
Tyndale Company, Inc Doylestown, United StatesJob Description · Job DescriptionThe Tyndale Company, a private, 7x Top Workplace winner and industry leading national supplier of arc-rated flame resistant (FR) clothing to the utilities, oil and gas, transportation, chemical manufacturing, molten metals, and NFPA 70E markets. W ...
-
Quality Assurance Analyst/Specialist
6 hours ago
Tyler Technologies Trenton, United StatesDescription · The Quality Assurance Analyst is responsible for supporting the planning, design and execution of system testing on simple to complex projects including simple forms, websites, product implementations, and fully custom-developed software. The QA Analyst works colla ...
-
Pharmacy Quality Assurance Analyst
3 weeks ago
IQVIA INC (US10) Wayne, United StatesIQVIA is seeking a Pharmacy Quality Assurance Analyst for Pharmacy Claims Engine team. This role will ensure our processes around Pharmacy Claims are occurring as intended and aim to improve those processes by automating them wherever possible. The impact of this role will be cre ...
-
Quality Assurance Analyst
1 week ago
Youth Consultation Service Somerdale, United StatesYouth Consultation Service (YCS) is a behavioral health and social services agency that has been caring for at risk children and families since 1918 in therapeutic residences, special education schools, in-home and in-community programs throughout NJ Quality Assurance, Assurance, ...
-
Quality Assurance Analyst
2 weeks ago
YCS Somerdale, United StatesYouth Consultation Service (YCS) is a behavioral health and social services agency that has been caring for at risk children and families since 1918 in therapeutic residences, special education schools, in-home and in-community programs throughout NJ. · Currently seeking a Quali ...
-
Analyst, Quality Assurance
1 week ago
Marsh McLennan Agency Conshohocken, United StatesAs a member of the Call Center team, the Analyst, Quality Control is responsible for monitoring, scoring and reporting on various departmental processes and productivity of the Call Center team members by utilizing quality control recording software. The primary focus of this rol ...
-
Billing Assurance Senior Analyst
1 week ago
Remote Technology Inc Wilmington, United StatesRemote is solving global remote organizations' biggest challenge: employing anyone anywhere compliantly. We make it possible for businesses big and small to employ a global team by handling global payroll, benefits, taxes, and compliance. Check out · to learn more or if you're ...
-
Quality Assurance Analyst
3 weeks ago
INTERNET PIPELINE Exton, United StatesQuality Assurance Analyst - QUALI017377 · DESCRIPTION/RESPONSIBILITIES: We are currently looking to add a QA Analyst to our team in. · Summary: We are looking for an enthusiastic QA analyst to work on our Quality Assurance team. The candidate should have an affinity for all thing ...
-
Quality Assurance Analyst
1 week ago
iPipeline Exton, United States· iPipeline is a leading provider of cloud-based software solutions for the life insurance and financial services industry. Through our SaaS solutions, we accelerate and simplify insurance sales, compliance, operations, and support. We provide process automation and seamless int ...
-
Analyst, Quality Assurance
3 weeks ago
CyberTec Malvern, United StatesClient: DaVita · Req # · Job Title: Analyst, Quality Assurance (IT) · Location: Malvern, PA · Duration: 6 months · (Pay Rate: $45/hr on C2C · Need only 4 year good fit candidate · Manual Testing, Database Testing for Migration to Cloud GCP/BQ Project · DutiesAnalyzes, t ...
Quality Assurance Analyst - Philadelphia, United States - InsideHigherEd
Description
Quality Assurance Analyst (Regulatory) 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
Quality Assurance Analyst (Regulatory) CVPF (Center for Cellular Immunotherapy)
Job Profile Title
Research Coordinator
Job Description Summary
The Quality Assurance Analysis 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 a crucial component of the success of on-going human clinical trials in immunotherapies.
Job Description
Duties include: