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GMP, QUALITY ASSURANCE ASSOCIATE I

Req ID:  11058
Date:  Oct 31, 2019
Location: 

Durham, NC, US, 27710

Personnel Area:  MEDICAL CENTER

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.

 

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:

  • Track and trend metrics and identify areas of concern
  • Write, revise, and review SOPs
  • Assist in managing quality-related matters during internal/external inspections
  • Prepare QSU Quality reports
  • Lead continuous improvement projects and initiatives
  • Attend meetings with Quality personnel
  • Assist with Deviation/Event management including corrective action and preventative action (CAPA) management and root cause analysis (RCA)
  • Develop, compose, and review analytical/QC, equipment and process qualifications and related data
  • Conduct environmental monitoring of facilities
  • Assist with vendor management and control
  • Participate in internal facility/process/data audits
  • Assist with batch review/release

 

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

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 QC/analytical data review
  • Experience in vendor management/audits
  • Experience in document management/review

 

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

 

 

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.

 


Nearest Major Market: Durham
Nearest Secondary Market: Raleigh