Quality Assurance Associate
Quality Assurance (QA) is responsible for ensuring that components,intermediates, drug substance, and drug productare of the quality required for their intended use and that qualitysystems are maintained. Withassistance and oversight,the QA Associate I will perform a variety of duties associated with theOffice of Regulatory Affairsand Quality in supportof the GMP programs at Duke University, including critical review ofdeviations and investigations,review/revision ofSOPs, release of materials, qualification of critical suppliers, reviewof product release, audit ofprograms under ORAQ’spurview, and quality training. This position will consult withmanufacturing operations staff, asapplicable/requested, toserve as a resource. This position reports to the Director ofRegulatory Affairs and Quality.
2770 GMP, QUALITY ASSURANCE ASSOCIATE I
Job Family Level
Full Time / Part Time
Regular / Temporary
Duke University is an Affirmative Action/Equal Opportunity Employercommitted to providing employment opportunity without regard to anindividual's age, color, disability, gender, gender expression, genderidentity, 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 robustexchange of ideas—an exchange that is best when the rich diversity ofour perspectives, backgrounds, and experiences flourishes. To achievethis exchange, it is essential that all members of the community feelsecure and welcome, that the contributions of all individuals arerespected, and that all voices are heard. All members of our communityhave a responsibility to uphold these values.
Essential Physical Job Functions:Certain jobs at Duke University and Duke University Health System mayinclude essential job functions that require specific physical and/ormental abilities. Additional information and provision for requests forreasonable accommodation will be provided by each hiring department.
Required: Bachelor's Degree
Required: 2 years of experience in a laboratory or regulated field,preferably related to GMP.Preferred:- 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
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