Quality Assurance Associate

3 weeks ago

Chapel Hill, United States Penn Foster Inc Full time

Posting Information

Department

Lineberger Compr Cancer Center-426801 Career Area

Research Professionals Posting Open Date

07/19/2023 Application Deadline

08/16/2023 Open Until Filled

No Position Type

Permanent Staff (EHRA NF) Working Title

Quality Assurance Associate Appointment Type

EHRA Non-Faculty Position Number

20050767 Vacancy ID

NF0007180 Full Time/Part Time

Full-Time Permanent FTE

1 Hours per week

40 Position Location

North Carolina, US Hiring Range

Dependent on Education/Experience Proposed Start Date

07/24/2023 Position Information

Primary Purpose of Organizational Unit

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. Position Summary

UNC’s Advanced Cellular Therapeutics Facility is looking for a qualified Quality Assurance Associate 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 the equipment lifecycle from onboarding, calibration, preventative maintenance, and decommissioning.

The role requires a person who understands Quality Systems in support of a cGMP Manufacturing Facility. This involves serving in leadership role regarding following and executing cGMP processes for all employees at the ACT Facility. Person will work to ensure that the products meet all required quality standards, manage and execute the yearly audit schedule, manage the critical document control for the entire site, and ensure all material and equipment vendors are approved in accordance with site SOPs.

The person must be able to work independently with little oversight and multi-task a number of ongoing activities. Additionally, the role must respond to facility issues quickly to have them resolved so as to not impact products for a patient. Minimum Education and Experience Requirements

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. Required Qualifications, Competencies, and Experience

Requires knowledge and experience in using Quality Systems in support of a cGMP Manufacturing Facility. Two years of previous Quality experience is necessary. Has excellent Word and Excel skills. Ability to write and execute deviation investigations, CAPA, and complete system audits. Ability to analyze data and information and report to management. Ability to work with others to help them understand Quality Systems and how to execute them. Preferred Qualifications, Competencies, and Experience

Prior experience working with transducing retrovirus for manufacturing of human cellular therapy products is highly desired. Understanding cell culture processes and how Quality Systems are applied to them is a bonus. Special Physical/Mental Requirements Campus Security Authority Responsibilities

Not Applicable.

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