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 responsiblefor Quality Control testing of the GMP facility, and projects manufactured therein, to ensure it is in control and in compliance with applicable regulations. The individualwill report to the GMP Quality Control 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.
- Perform duties as dictated by standard operating procedures (SOPs) for Quality Control 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 Quality Control 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 Quality Control 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 Quality Control-related procedures, documentation, and equipment. Notification of management of any Quality Control-related out of specification (OOS) result.
- Assistance 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.
Preferred Skills and Work Experience:- Up to two years of Quality Control experience, preferably in a GMP/regulated environment.- Good communication skills and the ability to work independently as well as part of team. Communicate and interact in a professional and courteous manner with co-workers, and others.- Must be team oriented and able to work in a highly collaborative work environment to complete complex tasks.- Must be able to manage multiple and rapidly changing priorities and have ability to quickly learn new skills and concepts.
Perform other related duties incidental to the work described herein.
1888 LAB RESEARCH ANALYST I
Job Family Level
Full Time / Part Time
Regular / Temporary
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Essential Physical Job Functions:Certain jobs at Duke University and Duke University Health System mayinclude essential job functions that require specific physical and/ormental abilities. Additional information and provision for requests forreasonable accommodation will be provided by each hiring department.
Work requires a bachelor's degree in botany, biology, zoology or otherdirectly related scientific field.
Work requires two years of research experience. A related master'sdegree may offset required years of experience on a 1:1 basis, e.g., atwo year master's degree in lieu of two years of experience.OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
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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.