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.
The Perelman School of Medicine at the University of Pennsylvania is the oldest and one of the finest medical schools in the United States. Penn is rich in tradition and heritage and at the same time consistently at the forefront of new developments and innovations in medical education and research. Since its founding in 1765 the School has been a strong presence in the community and prides itself on educating the leaders of tomorrow in patient care, biomedical research, and medical education. http://www.med.upenn.edu/
The Quality Assurance Leads are critical in supporting the CVPF Quality Management System and the Quality Plan.
QA Leads are responsible of providing expertise and oversight for quality and compliance support CVPF Functional Areas (e.g., Facilities, QC, Operations, Manufacture, Manufacture Ops, Document Control, Media, or as applicable) with the main goal of ensuring that all final clinical products released by CVPF are compliant and of the highest quality. This position will report to either the CVPF QA Manager or the QA Director. Specific Responsibilities are listed below:
- Assist in coordinating and overseeing operational compliance monitoring activities, including providing subject matter expertise to address/resolve quality and compliance related questions.
- Conduct internal inspections (or gap assessments) of processes to ensure compliance, and to streamline and optimize existing processes.
- Lead Continuous Improvement projects resulting from these aforementioned ongoing gap assessments, or if directly assigned by QA Management. Please note that Project Management skills are required in order to succeed in this role.
- Assist in completing investigations, deviations, Out-of-specification reports, etc. Assist in developing robust CAPAs to minimize reocurrence of non-conformances and to prevent potential systemic compliance issues.
- Quality Representative in Functional Area Team Meetings, serving as the go-to person answering quality related questions.
- Author, review and/or approve related documents and records, such as for example, SOPs, Work Instructions, IQ/OQ/PQ, Analytical Test Methods, Specifications, etc
- Assists and facilitate information in support of regulatory facility inspections as needed.
- Support the Change Management process by authoring and managing change controls
- Review and approve Validation Plans and Scientific Investigation Reports (SIRs), including raw data review of lab test results.
- Create and deliver training modules of quality topics. Facilitate training related activities from a quality standpoint. Support the training program as required by QA Management.
- Must be highly knowledgeable in cGMPs, GLPs, GDPs (e.g., FACT and FDA)
- Provide support to operational areas, such as inspecting and releasing raw materials, performing Line Clearances, Environmental Monitoring, Product Release, Product Receipt, etc, as assigned by QA Management.
- Responsible for compiling Quality Metrics.
- May supervise employees and/or train and guide others.
- Serve as the QA Rep or Process Owner, as assigned (for example, the Materials Management Program, the Training Program, the Document Management program, Environmental Monitoring Plan, Supplier Qualification Program, Personnel Monitoring, Media, and others).
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.