Durham, North Carolina

This Position is Fully Grant Funded

School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

Job Title: GMP, Quality Assurance Associate I                   

                                   

Primary role:

 

Quality Assurance (QA) for current Good Manufacturing Practice (cGMP)-compliant programs is responsible for ensuring that components, intermediates, drug substance, and drug product are of the quality required for their intended use and that quality systems are maintained. With assistance and oversight, the QA Associate I will perform a variety of duties associated with the Office of Regulatory Affairs and Quality in support of the cGMP programs at Duke University, including critical review of deviations and investigations, review/revision of SOPs, inspection/release of materials, qualification of critical suppliers, review of batch records for product release, audit of programs under ORAQ’s purview, and quality training. This position will consult with manufacturing operations staff, as applicable/requested, to serve as a resource. This position, which is suitable for an early-career quality professional,  reports directly to the Duke Human Vaccine Institute CGMP Program (DGP) Manager of the Quality Systems Unit (QSU) and overall to the Director of Regulatory Affairs and Quality of the Duke University School of Medicine.

 

Essential tasks/responsibilities:

 

In conjunction with other members of the QA Staff and/or Management:

  • Provide quality support for external manufacturing campaigns (75%)
    • Review/approve third-party master production records and other manufacturing records pre-execution, if necessary
    • Review/approve third-party master production records and other manufacturing records post-execution to ensure they meet DGP requirements
    • Follow-up on and keep track of third party deviations/CAPAs affecting DGP products
    • Assist in communication of quality matters with Sponsor/client
    • Assist with batch review/release
  • Assist in vendor management (20%)
    • Perform vendor qualification/requalification according to internal DGP procedures
    • Conduct qualification audits, as needed.  Assist in composition of audit reports and observation forms.  Review audit report responses and disseminate responses to qualification team.
    • Assist in execution of quality agreements
    • Assist in documentation and resolution of vendor non-conformances
  • Participate in other quality roles/responsibilities (5%)
    • Prepare QSU Quality reports
    • Lead continuous improvement projects and initiatives
    • Attend meetings with Quality personnel
    • Participate in internal facility/process/data audits

 

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

 

Education/training:

 

Required: Bachelor’s degree

Preferred: None

 

Experience:

 

Required: 2 years of experience in quality assurance and/or quality control, preferably related to GMP.  Experience in early clinical phase vaccine manufacturing a plus.

Preferred:

  • Experience in deviation/CAPA management and RCA
  • Experience in vendor management/audits
  • Experience in cGMP manufacturing/analytical processes

 

OR ANY OTHER EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE                     

 

Skills:

Required:

  • Working knowledge of GMP
  • Organizational and time management skills with the ability to handle a multitude of tasks.
  • Working knowledge of electronic databases.
  • Attention to detail.
  • Ability to work independently or in a team environment
  • Excellent verbal, written, and interpersonal skills conducive to interactions with team members at all levels.
  • Possess good problem-solving skills

 

Special competencies/credentials:

           

Required: None

            Preferred: None

 

The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description

Minimum Qualifications

 

 

Education

Required: Bachelor's Degree

 

Experience

 

Required: 2 years of experience in a laboratory or regulated field, Preferred: preferably related to GMP. - Experience in preparing for external audits or site visits. - Experience working in or with a Quality Department. A Master's or PhD can substitute for 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.

 

Durham, North Carolina

As a world-class academic and health care system, Duke Health strives to transform medicine and health locally and globally through innovative scientific research, rapid translation of breakthrough discoveries, educating future clinical and scientific leaders, advocating and practicing evidence-based medicine to improve community health, and leading efforts to eliminate health inequalities.

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