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 Associate Director, Quality Assurance.
In conjunction with other members of the QA Staff and/or Management:
Assist in the review/approval of analytical QC, in-process, release, and stability data supporting product testing
Assist in managing raw materials and supplies for manufacturing
Provide support for fill/finish and product labeling and packaging operations
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 and testing of critical utilities (i.e. water for injection)
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.
2 years of experience in quality assurance and/or quality control, preferably related to GMP. Experience in early clinical phase vaccine manufacturing a plus.
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
The Duke Human Vaccine Institute (DHVI) continues to lead with cutting edge vaccine research against infectious diseases that impact global health. The investigators at the DHVI conduct basic and translational research to develop novel vaccines, therapeutics and diagnostics for diseases such as HIV-1, tuberculosis, influenza, syphilis, gonorrhea, cytomegalovirus, rotavirus, parainfluenza, zika flavivirus, plague and now SARS-CoV-2. Several DHVI investigator led basic science discoveries are currently being produced in Good Manufacturing Practice (CGMP) facilities for early phase vaccine trials.