Quality Assurance Associate

Location
Pennsylvania, United States
Posted
23 Sep 2020
End of advertisement period
22 Nov 2020
Ref
JR00012977
Academic Discipline
Life sciences, Biological Sciences
Contract Type
Permanent
Hours
Full Time

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.

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
Assistant Manager C

Job Description Summary

The Quality Assurance Associate will work within the Clinical Cell and Vaccine Production Facility (CVPF) for the review and release of cell products manufactured at our facility. This position is a crucial component of the success of on-going clinical trials in immunotherapies.

Main duties include:

  • Review of in process manufacturing records and product release documentation, verifying that calculations, unique identifiers, and all applicable records adhere to Good Documentation Practices and applicable SOPs.
  • Communicate errors and deviations identified during batch record review and follow up to ensure errors are resolved and investigations are initiated and progressing in a timely manner
  • Conduct product release functions; therefore, attention to detail and a sense of urgency are crucial. This position will be accountable and responsible of ensuring CVPF products are released according to schedule.
  • Anticipate potential roadblocks that may affect product release and alert management, as applicable.
  • Other Duties as assigned by management

Job Description

QUALIFICATIONS

Required:

  • Previous experience conducting review of controlled documentation is required. Demonstrated experience in product batch record review according to cGMP guidelines, writing/revising SOPs, working cGMP knowledge, HIPAA requirements.
  • 3-5 years of experience working in an FDA/GMP regulated industry, or similar.
  • BS in Biology or equivalent scientific discipline; a combination of education and related work experience will be considered
  • Strong analytical skills and detail oriented
  • Experience meeting critical deadlines; maintaining precision and accuracy while performing under pressure
  • Attention to detail is crucial to succeed in this role. The applicant must have an excellent track record or conducting error free review of documentation.
  • Weekend work may be required, due to clinical manufacture schedule.

Preferred:

  • Previous working experience in a lab setting and familiarity with: ELISAs, flow cytometry, PCR-based assays, sterility testing, etc
  • Previous experience in the following: CAPA, Root Cause Analysis, Change Management, Deviations, Inventory Management
  • Knowledge in Cell and Gene Therapy and Working knowledge of FACT

This position is contingent upon funding.

Job Location - City, State
Philadelphia, Pennsylvania

Department / School
Perelman School of Medicine

Pay Range
$50,684.00 - $91,232.00

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.

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.

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