GMP QUALITY CONTROL CELL THERAPY TECHNICIAN
- Employer
- Duke University
- Location
- Durham, NC
View more
- Administrative Jobs
- Academic Affairs, Research Staff & Technicians
- Employment Type
- Full Time
- Institution Type
- Four-Year Institution
Job Details
GMP QUALITY CONTROL CELL THERAPY TECHNICIAN
Marcus Center for Cellular Cures (MC3)
The Marcus Center for Cellular Cures has an exciting opportunity for a GMP Quality Control Cell Therapy Technician located in The Robertson cGMP Laboratory Durham, N.C. More information about the Marcus Center and the Robertson cGMP Laboratory is located at the following link(s):
https://marcuscenter.duke.edu/about-us/mission/
https://marcuscenter.duke.edu/resources/robertson-gmp-lab/
OCCUPATIONAL SUMMARY:
The incumbent in this position is responsible for highly complex and specialized testing of cellular products for clinical trials and commercial operations. In addition, this individual will be responsible for QC testing of the GMP facility, and projects manufactured therein, to ensure it is in control and in compliance with applicable regulations. The individual will report to the GMP QC Supervisor. The individual filling this position will be an integral member of a team working together to produce the highest quality clinical material for novel cellular therapies.
WORK PERFORMED:
- Perform duties as dictated by standard operating procedures (SOPs) for QC and release testing of cellular product manufacturing and under G'X'P (GLP, GTP, GMP, GDP) guidelines as directed.
- Perform sterility, endotoxin, cell characterization by flow cytometry, and other required testing to support in-process testing and final product release. Ship samples to outside vendors for quality control testing.
- Operate QC instrumentation needed for release testing such as cell counting devices, micropipettes, Biological Safety Cabinets, flow cytometers, and endotoxin testing devices.
- Serve as a resource to the GMP QC supervisor in identifying and assessing the appropriate complement of resources and support needed to successfully complete quality control related work.
- Maintain responsibility and confidentiality for patient identification, specimen labeling and specimen verification.
- Use knowledge of laboratory safety and infection control procedures and practices to safely perform required work including universal precautions and hazardous chemical handling.
- Perform routine environmental monitoring of the GMP facility. Perform duties in a clean room environment while fully gowned (hood, mask, coverall, boots, gloves, etc.) following GMP guidelines.
- Operate instrumentation needed for environmental monitoring.
- Perform Quality Control activities for the facility, including checking expiration dates for supplies and tracking maintenance schedule for equipment, including biosafety cabinets, pipettes, centrifuges and other specialized equipment.
- Maintain sufficient inventory of supplies and reagents for performance of duties; clean and maintain laboratory equipment in good working order.
- Maintenance of QC-related procedures, documentation, and equipment. Notification of management of any QC-related out of specification (OOS) result.
- Assist in writing and review of validations, research plans and reports, SOPs, and batch records as required.
- Work with GMP QC Supervisor to ensure the facility is in compliance for governing regulations.
- Help to maintain orderly lab spaces. Participate in lab inspections and work with inspectors as needed
- Use dexterity, knowledge, and ability to complete assigned laboratory tasks and skills, with attention to detail and compliance with all appropriate laboratory regulatory and safety requirements.
- Perform other related duties incidental to the work described herein.
SKILLS:
- Good interpersonal skills. Ability to work and maintain strong relationships with the department manager, members of the GMP team and other departmental staff.
- Good communication skills and the ability to work independently as well as part of team.
- Attention to detail
- Ability to read and understand Standard Operating Procedures.
Requisition Number
401546175
Location
Durham
Duke Entity
MEDICAL CENTER
Job Code
1888 LAB RESEARCH ANALYST I
Job Family Level
11
Full Time / Part Time
FULL TIME
Regular / Temporary
Regular
Shift
First/Day
Minimum Qualifications
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
Education
Work requires a bachelor's degree in botany, biology, zoology or other directly related scientific field.
Experience
Work requires two years of research experience. A related master's degree may offset required years of experience on a 1:1 basis, e.g., a two year master's degree in lieu of two years of experience. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
Auto req ID
108965BR
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.
Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
PI107055861
Organization
History
Duke University was created in 1924 by James Buchanan Duke as a memorial to his father, Washington Duke. The Dukes, a Durham family that built a worldwide financial empire in the manufacture of tobacco products and developed electricity production in the Carolinas, long had been interested in Trinity College. Trinity traced its roots to 1838 in nearby Randolph County when local Methodist and Quaker communities opened Union Institute. The school, then named Trinity College, moved to Durham in 1892, where Benjamin Newton Duke served as a primary benefactor and link with the Duke family until his death in 1929. In December 1924, the provisions of indenture by Benjamin’s brother, James B. Duke, created the family philanthropic foundation, The Duke Endowment, which provided for the expansion of Trinity College into Duke University.
As a result of the Duke gift, Trinity underwent both physical and academic expansion. The original Durham campus became known as East Campus when it was rebuilt in stately Georgian architecture. West Campus, Gothic in style and dominated by the soaring 210-foot tower of Duke Chapel, opened in 1930. East Campus served as home of the Woman's College of Duke University until 1972, when the men's and women's undergraduate colleges merged. Both men and women undergraduates now enroll in either the Trinity College of Arts & Sciences or the Pratt School of Engineering. In 1995, East Campus became the home for all first-year students.
Duke maintains a historic affiliation with the United Methodist Church.
Home of the Blue Devils, Duke University has about 13,000 undergraduate and graduate students and a world-class faculty helping to expand the frontiers of knowledge. The university has a strong commitment to applying knowledge in service to society, both near its North Carolina campus and around the world.
Mission Statement
"James B. Duke's founding Indenture of Duke University directed the members of the University to 'provide real leadership in the educational world' by choosing individuals of 'outstanding character, ability, and vision' to serve as its officers, trustees and faculty; by carefully selecting students of 'character, determination and application;' and by pursuing those areas of teaching and scholarship that would 'most help to develop our resources, increase our wisdom, and promote human happiness.'
“To these ends, the mission of Duke University is to provide a superior liberal education to undergraduate students, attending not only to their intellectual growth but also to their development as adults committed to high ethical standards and full participation as leaders in their communities; to prepare future members of the learned professions for lives of skilled and ethical service by providing excellent graduate and professional education; to advance the frontiers of knowledge and contribute boldly to the international community of scholarship; to promote an intellectual environment built on a commitment to free and open inquiry; to help those who suffer, cure disease, and promote health, through sophisticated medical research and thoughtful patient care; to provide wide ranging educational opportunities, on and beyond our campuses, for traditional students, active professionals and life-long learners using the power of information technologies; and to promote a deep appreciation for the range of human difference and potential, a sense of the obligations and rewards of citizenship, and a commitment to learning, freedom and truth.
“By pursuing these objectives with vision and integrity, Duke University seeks to engage the mind, elevate the spirit, and stimulate the best effort of all who are associated with the University; to contribute in diverse ways to the local community, the state, the nation and the world; and to attain and maintain a place of real leadership in all that we do.”
Get job alerts
Create a job alert and receive personalized job recommendations straight to your inbox.
Create alert