GMP QUALITY CONTROL CELL THERAPY TECHNICIAN

Job description


diversity employer



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.

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Job No:
Posted: 1/18/2019
Application Due: 3/19/2019
Work Type:
Salary: