COORDINATOR, QUALITY ASSURANCE & COMPLIANCE - DUKE VACCINE IMMUNOGENICITY PROGRAMS (QADVIP)
Duke University

Durham, North Carolina


School of Medicine:

Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.

Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

The Quality Assurance for Duke Vaccine Immunogenicity Programs (QADVIP) oversees Good Clinical Laboratory Practice (GCLP) compliance by multiple laboratories at Duke and outside of Duke involved in processing and immunogenicity endpoint assessment of specimens from HIV, SARS CoV-2, influenza, malaria, and other vaccine phase I-III clinical trials.

QADVIP services:
Audits and Monitoring; Document Review/Management and Document Control; Assi stance with Regulations/Guidance; Quality Consultation; GCLP Training; Certificate of Analysis Review; Assay Validation; Computerized System Val dation

Occupational Summary
Perform a variety of duties associated with QADVIP, including review and management of standardized procedures/policies/reports, the development of new policies and procedures, collaboration with and support of laboratory staff in quality assurance policies and procedures, auditing and monitoring laboratory/vendor programs and activities.

Work Performed

  • Perform a variety of complex and independent activities involved in the collection, analysis, and documentation, of laboratory activities and documents, as related to quality assurance, quality control, safety management and compliance with applicable policies and standards.
  • Evaluate and interpret collected quality indicators and prepare written reports and analyses setting forth progress, adverse trends and appropriate recommendations or conclusions.
  • Conduct audits, write audit reports, and work with laboratory units to maintain compliance with regulatory standards.
  • Utilize electronic quality management system to manage document control, and review deviations/non-conformances and associated corrective and preventive actions.
  • Determine the validity and appropriateness of quality assurance criteria and measures utilized by the QADVIP; make appropriate recommendations to the laboratory unit staff.
  • Maintain liaison with laboratory units; represent QADVIP on various quality assurance audit and review committees.
  • Plan and conduct, in service orientation and education, for laboratory management and staff: on quality assurance policies, procedures, and documentation requirements.
  • Stay abreast of new developments in the field of Quality Assurance and Quality Control; recommend new policies and revise existing policies/procedures for compliance standards.
  • Perform other related duties incidental to the work described herein.

Minimum Qualifications
Education

Work generally requires a bachelor's degree in a biological Science.

Experience
Work requires six years of experience quality assurance or quality control related to clinical trials. A Master's degree in a related field may be substituted for 2 years of required experience OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE.

Duke 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 essentialjob 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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