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Quality Associate (Shifted Workweek)


New York Stem Cell Foundation

Job Location

619 West 54th Street, Floor 3 New York, NY 10019
New York, NY 10001
United States

Job Description

New York, New York Research Institute – Cell Therapy Full Time

The New York Stem Cell Foundation (NYSCF) Research Institute is a growing and successful nonprofit whose mission is to accelerate cures through stem cell research.

NYSCF is bringing cutting-edge stem cell research directly into the clinic. The NYSCF Quality team is seeking a Quality Associate as a key participant in this effort. You will be responsible for executing the Quality Assurance and Quality Control functions under the Senior Director, Quality Assurance supervision.

The Quality Associate is a full-time position located at the NYSCF Research Institute in New York, NY. This position is a non-exempt, full-time position based on a 35-hour shifted workweek, Thursday through Monday.

What you'll do:

    • Perform QC testing of raw materials, in-process samples and intermediate and final product
    • Perform test method qualification/validation, method transfer and equipment qualification
    • Perform Environmental Monitoring sampling and testing
    • Perform ordering, testing and releasing of raw materials and supplies for GMP manufacturing
    • Perform GMP equipment maintenance and calibration
    • Assist GMP manufacturing team as needed
    • Other duties as assigned

What we're looking for:

    • Bachelor of Science in Biology or related field
    • 2+ years experience in a pharmaceutical/biotech device industry; Quality experience preferred
    • Knowledge of cGMP regulations
    • Experience with aseptic processing
    • Experience in environmental monitoring and microbiological testing
    • Knowledge in quality systems including change control, deviations and CAPA
    • Excellent written and oral communication skills
    • Expertise using MS Office applications (i.e., Word and Excel)
    • Must be able to work a shifted workweek (Thursday - Monday)

We offer all full-time employees a comprehensive benefits package that goes into effect on the first of the month following your start date.

NYSCF is an equal opportunity employer and we value diversity in our company. It ensures equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, veteran status, or any other characteristic protected by law.

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