Quality Assurance Associate

Location
Pennsylvania, United States
Posted
27 May 2019
End of advertisement period
27 Jul 2019
Ref
40-32142
Contract Type
Permanent
Hours
Full Time

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.

School/Center Overview    

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/

Duties    

The Gene Therapy Program (GTP) and Orphan Disease Center (ODC) are entering a new era of unprecedented opportunity with great potential to reshape the face of medicine as we know it. Our discoveries have set the stage for successful treatments and possibly even cures for devastating genetic diseases. Our R&D organization has a translational infrastructure that includes: technology discovery, specialized immunology assays operating under GLP, a Vector Core/Manufacturing unit that conducts GMP comparable work, and a large non-clinical program for animal testing under GLP including large NHP and rodent vivaria. 

Our Quality Assurance (QA) department is currently on the hunt for a QA Associate supporting the development, manufacture, and testing of viral vectors for early phase clinical trials. 

As a QA Associate, your activities are critical to ensuring compliance with Good Laboratory Practices (GLP). You will be performing audits of translational research labs against written lab protocols and Standard Operating Procedures (SOP); reviewing SOP’s and updating formatting to comply with our standards; perform validation, batch record, and final written report reviews; perform facility audits as well as pre-audit inspections; and with input from the Senior Director, use your discretion and independent judgment in providing recommended corrective actions to management and the study directors.

Also, you will be able to provide guidance and training to staff as it relates to GLP and compliance.

Position is contingent on continued funding.

Qualifications    

  • A Bachelor’s degree in life sciences and 5-7 years of experience in a quality assurance role or an equivalent combination of education and experience required; 
  • Experience working in GLP/GMP environment and strong knowledge of GLP/GMP’s required
  • Experience in cell and gene therapy is strongly preferred. 
  • Demonstrated ability to work collaboratively, multi-task, and prioritize in a fast-paced environment a must 
  • Strong analytical skills and attention to details required
  • Must have demonstrated experience meeting critical deadlines. 
  • Experience with Microsoft word, excel and access required. Proficiency with access databases preferred.

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.