Quality Assurance Lead
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.
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.
Job Profile Title
Research Coordinator Senior
Job Description Summary
The Quality Assurance Lead is critical in supporting the CVPF Quality Management System (QMS). The QA Lead is responsible for supporting the CVPF by providing current Good Manufacturing Practice (cGMP) expertise and oversight to the entire facility. This role covers all of the CVPF Functional Areas (Facilities, Quality Control Testing, Operations, Manufacturing, Environmental Monitoring, Media Prep, and Document Control) with the goal of ensuring that all final clinical products released by CVPF are of the highest quality and compliance. 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 every year. The QA Lead will directly report to the CVPF QA Manager.
Specific Responsibilities are listed below:
- Author, review, and approve controlled documents (SOPs, processing forms, work instructions, batch records, etc.)
- Conduct internal audits of CVPF activities against current SOPs and regulatory standards. Document observations as major/minor and recommend areas for improvement.
- Compile monthly, quarterly, and annual metrics for the periodic QMS reports.
- Manage the deviation investigation system. Ensure deviations are adequately investigated and closed within 30 calendar days. Assist investigators with root cause analysis and documentation of immediate and long-term corrective actions (CAPAs).
- Qualify new and existing vendors.
- Perform retrospective analysis of products, deviations, CAPAs, and other QMS metrics to identify trends.
- Lead continuous improvement projects resulting from audits, or if directly assigned by the QA Manager.
- Attend cross-functional team meetings to provide quality updates and communication.
- Review other quality documents such as validation plans, change controls, equipment IOPQs, and scientific reports as needed.
- Prep facility for inspections/audits by external parties and regulatory bodies. Participate in audit as instructed by the QA Manager.
- Train staff on quality procedures and perform annual cGMP training for all staff.
- Maintain tracking systems and manage databases for all aspects of the QMS.
- Assisting the CMC & Regulatory group as needed to help with raw material inspection, apheresis receipt, and finished product release.
- Other tasks as needed by the QA Manager.
- BS/BA in a biomedical science, biotechnology, engineering, or a related technical field and 3 to 5 years of experience or an equivalent combination of education and experience required.
- 1-3 years of experience in a GLP research lab or equivalent.
- Strong knowledge of cell and gene therapy principles and technologies
- Highly skilled with Microsoft Excel and Access
- Master’s degree in biomedical science, biotechnology, engineering or a related technical field.
- 3-5 years of experience in GMP manufacturing facility with 1-3 years of experience specifically in Quality Assurance.
- Previous experience with Phase I IND clinical trials.
- Working knowledge of FACT Common Standards for Cellular Therapy, 21 CFR 210 & 211, and ICH guidelines
- Previous experience as a technician in a cell and gene therapy lab.
This position is contingent upon funding.
Job Location - City, State
Department / School
Perelman School of Medicine
$42,953.00 - $77,315.00
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.
Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.