QA - Material Release Specialist
University of North Carolina at Chapel Hill

Department:

Lineberger Compr Cancer Center-426801

Research Professionals

12/03/2024

12/17/2024

No

Permanent Staff (EHRA NF)

QA - Material Release Specialist

EHRA Non-Faculty

20063903

NF0008714

Full-Time Permanent

1

40

North Carolina, US

Dependent on Education/Experience

12/30/2024

A global higher education leader in innovative teaching, research and public service, the University of North Carolina at Chapel Hill consistently ranks as one of the nation's top public universities. Known for its beautiful campus, world-class medical care, commitment to the arts and top athletic programs, Carolina is an ideal place to teach, work and learn.One of the best college towns and best places to live in the United States, Chapel Hill has diverse social, cultural, recreation and professional opportunities that span the campus and community.University employees can choose from a wide range of professional training opportunities for career growth, skill development and lifelong learning and enjoy exclusive perks for numerous retail, restaurant and performing arts discounts, savings on local child care centers and special rates on select campus events. UNC-Chapel Hill offers full-time employees a comprehensive benefits package, paid leave, and a variety of health, life and retirement plans and additional programs that support a healthy work/life balance.

The UNC School of Medicine has a rich tradition of excellence and care. Our mission is to improve the health and wellbeing of North Carolinians, and others whom we serve. We accomplish this by providing leadership and excellence in the interrelated areas of patient care, education, and research. We strive to promote faculty, staff, and learner development in a diverse, respectful environment where our colleagues demonstrate professionalism, enhance learning, and create personal and professional sustainability. We optimize our partnership with the UNC Health System through close collaboration and commitment to service.
OUR VISION
Our vision is to be the nation's leading public school of medicine. We are ranked 2nd in primary care education among all US schools of medicine and 5th among public peers in NIH research funding. Our Allied Health Department is home to five top-ranked divisions, and we are home to 18 top-ranked clinical and basic science departments in NIH research funding.
OUR MISSION
Our mission is to improve the health and well-being of North Carolinians and others whom we serve. We accomplish this by providing leadership and excellence in the interrelated areas of patient care, education, and research.
Patient Care: We will promote health and provide superb clinical care while maintaining our strong tradition of reaching underserved populations and reducing health disparities across North Carolina and beyond.
Education: We will prepare tomorrow's health care professionals and biomedical researchers by facilitating learning within innovative curricula and team-oriented interprofessional education. We will cultivate outstanding teaching and research faculty, and we will recruit outstanding students and trainees from highly diverse backgrounds to create a socially responsible, highly skilled workforce.
Research: We will develop and support a rich array of outstanding health sciences research programs, centers, and resources. We will provide infrastructure and opportunities for collaboration among disciplines throughout and beyond our University to support outstanding research. We will foster programs in the areas of basic, translational, mechanistic, and population research.

UNC's Advanced Cellular Therapeutics Facility is looking for a qualified Quality Assurance - Material Release Specialist to join their team to support the work of developing and producing cellular therapy products for patients receiving adoptive cell therapy for the treatment of cancer. They will be responsible for a number of functions around the release of incoming materials, the approval of vendors, and the execution of quality duties in support of manufacturing.

This person is responsible for overseeing the process for receipt, inspection, and disposition of materials. The role will create technical documents to support release of material for manufacturing working with both Production and Quality Assurance to ensure they meet the needs of the process. The person will need to investigate requested materials, ensure they meet the GMP and regulatory requirements to be used in a GMP manufacturing process. The person will oversee the inspection of all materials, conducting a review of documents and ensuring the material meets the facilities release requirements. The role will than apply a disposition to the material allowing it to be either released for use or rejected and must be returned to the vendor. This person will also segregate Research Use only Materials to ensure they are not mixed up with fully released materials. This person will follow standard operating procedures in the execution of their activities.

This person will also execute the Quality vendor approval process. They will assess requests to use new vendors, execute risk assessments about the vendor to ensure they do not have a high-level risk involved with purchasing material from the said vendor. They will also assess changes to vendor materials when the ACT Facility is notified and execute change controls to document updates.

This person will also support quality activities by executing and completing investigations into deviations from process and procedure.

The person must be able to work independently with little oversight and multi-task several ongoing activities at once. Additionally, the role must respond to material issues quickly to have them resolved so as to not impact products for a patient.

Relevant post-Baccalaureate degree required (or foreign degree equivalent); for candidates demonstrating comparable independent research productivity, will accept a relevant Bachelor's degree (or foreign degree equivalent) and 3 or more years of relevant experience in substitution. May require terminal degree and licensure.

Working in a GMP manufacturing environment in either manufacturing, QC, or QA.

Knowledge of Microsoft Office software (Word, Excel, Power Point)

Knowledge of Good Manufacturing Practices and how they are utilized in an academic manufacturing environment.

Relevant experience working in a Good Manufacturing Practices environment.

Not Applicable.