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Scientist III Quality Assurance

Company: St. Jude Children's Research Hospital
Location: Raleigh
Posted on: September 14, 2020

Job Description:

With resources to help you succeed and develop your career, we also offer generous relocation assistance.St. Jude was the first pediatric cancer research center in the U.S. to open an on-site Good Manufacturing Practice (GMP) facility. Launched in 2003, the St. Jude GMP facility has become one of the nation's leading biomanufacturing facilities located on an academic campus.The GMP facility provides St. Jude investigators a key advantage: the ability to develop and produce innovative therapeutics that may not find an initial investment by a major pharmaceutical company. The facility also supports the manufacture of products for use in preclinical studies.

We are looking for a Scientist III in the Quality Assurance department. Candidate will monitor compliance with applicable regulatory standards and perform diverse tasks including developing and updating Standard Operating Procedures (SOPs); inspect and release production suites; review controlled documentation including batch production records, environmental monitoring records, and equipment logs; release finished products for clinical use; and perform training on topics related to Good Manufacturing Practices (GMP) and Good Tissue Practices (GTP).

The selected candidate will be expected to have the following responsibilities:


  • As directed by supervisor, routinely monitor production activities while in progress by checking batch records for accuracy and cleaning and use logs for completeness.
  • Review fully executed batch records and release records. Release products for clinical administration.
  • Perform inspections/audits as directed to ensure compliance with all applicable accrediting or regulatory bodies (i.e., Food and Drug Administration, (FDA), Foundation for the Accreditation of Cellular Therapy (FACT), United States Department of Agriculture, (USDA), etc.)
  • Investigate deviations and assist staff with electronic deviation reporting. Monitor corrective and preventive actions for completion. Review deviation reports for trends and report findings to management.
  • Perform internal audits to assess compliance with Quality Management System. Participate in vendor audits for the purpose of supplier qualification or investigation of Quality issues.
  • Review, revise, and write standard operating procedures and job aids that accurately define the scope of operations performed by the QA compliance team.
  • Develop training curriculum for SOPs and GMP/GTP/FACT regulations and standards. Lead group training events.
  • Develop and refine competency and proficiency exercises for QA compliance group.
  • Audit competency and proficiency exercises for personnel in the GMP facility.
  • Maintain FACT compliance and update FACT compliance application annually. Implement changes to Quality System to address new standards.
  • Contribute to outcome analysis activities to monitor and trend quality attributes for cellular therapy products.


    • Bachelor's degree in chemistry, biology or a related field required.
    • Master's degree preferred


      • Two (2) years of experience in a laboratory or manufacturing setting with QC/QA responsibility required.
      • Certification from the American Society for Quality, (ASQ), or Regulatory Affairs Professionals Society, (RAPS), is preferred but not required.

        St. Jude is an Equal Opportunity EmployerNo Search Firms:St. Jude Children's Research Hospital does not accept unsolicited assistance from search firms for employment opportunities. Please do not call or email. All resumes submitted by search firms to any employee or other representative at St. Jude via email, the internet or in any form and/or method without a valid written search agreement in place and approved by HR will result in no fee being paid in the event the candidate is hired by St. Jude.

Keywords: St. Jude Children's Research Hospital, Raleigh , Scientist III Quality Assurance, Other , Raleigh, North Carolina

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