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Posted Job Title
GLP Archivist, Training & Electronic Documentation Coordinator
Job Profile Title
Research Coordinator Senior
Job Description Summary
The Gene Therapy Program (GTP) is entering a new era of unprecedented opportunity with the 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.
The laboratory of Dr. Jim Wilson, at GTP of the University of Pennsylvania, has been a leader in the development of innovative vector technology for close to three decades. We have emerged as the âœgo-toâ organization for public and private partners, who want to participate in the gene therapy space. Currently, we are positioned to lead another round of vector innovation and establish pre-clinical and clinical proof-of-concept in therapeutic applications of in-vivo genome editing.
Continuation of all GTP positions is contingent upon funding.
The GLP Archivist, Training and Electronic Documentation Coordinator is a member of the Good Laboratory Practice (GLP) Quality Assurance (QA) team within the Gene Therapy Program (GTP) at the University of Pennsylvania and reports directly to the Director of Quality Assurance under the Supervision of the Executive Director of Regulatory Affairs and Compliance. Responsibilities for this position include archiving raw data, documentation, protocols, specimens and interim and final reports in accordance with Good Laboratory Practice (GLP) regulations. Maintaining an index/catalog to ensure that all study associated components are stored under appropriate conditions in accordance regulations and to ensure that they can be found in an orderly and expedited retrieval manner. Additional responsibilities include managing and maintaining the SOP document system and assisting with oversight of personnel training files. As the QA moves from a primarily paper based system to 21 CFR Part 11 compliant electronic data capture in-life and post-life system, this position will be the primary QA contact for questions related to the system as it relates to troubleshooting issues that arise during the conduct of the studies, ensuring appropriate documentation is maintained and up-to-date and can be retrieved in an expedited manner during external Sponsor or Health Authority audits.
This position requires independent judgment and discretion in providing recommended corrective actions to Director of QA related to responsibilities. The individual for this position may also perform audits of raw data and final reports of basic to medium complexity for both routine and specialty study designs.
- A Bachelorâ™s degree in life sciences and 3-5 years of experience in a quality assurance role or an equivalent combination of education and experience is 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 attention to details required.
- Must have demonstrated experience meeting critical deadlines.
- Experience with Microsoft word, excel and access required.
- Proficiency with access databases preferred.
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.
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.
Internal Number: JR00017809
About University of Pennsylvania
Penn has a long and proud tradition of intellectual rigor and pursuit of innovative knowledge, begun by Benjamin Franklin in 1740. That tradition lives today through the creativity, entrepreneurship, and engagement of our faculty, students, and staff. Academic life at Penn is unparalleled, with an undergraduate student body of 10,000 from every U.S. state and around the world. The entering class of 2015 is the most talented and diverse in Penn's history. Consistently ranked among the top 10 universities in the country, Penn welcomes an additional 10,000 students to our top-ranked graduate and professional schools.