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Quality Assurance Specialist

Company: Arrowhead Pharmaceuticals
Location: Madison
Posted on: November 22, 2021

Job Description:

The PositionThe Quality Assurance Specialist I will participate in the material control operations and activities in support of the GMP Manufacturing and Quality departments at the Arrowhead Madison site. The incumbent will coordinate activities across multiple departments to ensure proper control over incoming materials, including storage conditions, labeling, testing, and QA disposition. The incumbent will also participate in general quality assurance auditing including, but not limited to, review of analytical data, equipment maintenance data, and general documentation. Responsibilities Review and perform QA disposition of all incoming raw materials intended for GMP manufacturing, including proper labeling of packaging/containers (Released, Quarantine, Rejected) according to Arrowhead Quality ProceduresInteract with representatives from other departments, including CMC Manufacturing, QC, and Facilities, to obtain the necessary information for proper release of raw materialsReview and approve raw material analytical testing data Manage the list of approved raw material GMP vendorsAssist with the GMP Vendor qualification programPrepare and/or assist with raw material related investigations/deviations, as appropriatePerform release of controlled documents such as logbooks and other forms, as well as a final quality review on completed forms, weight set verifications, label reconciliations Scan and upload executed documents to the EDMS, properly categorize within the system, and route for verification/approvalAdditional duties as assigned Requirements: Bachelor's degree in a science fieldAt least two years of experience working in a regulated environment with preference to quality assurance auditing and/or raw material experienceWorking knowledge of drug Good Manufacturing Practices (GMP) regulationsCompetent knowledge of and ability to use Microsoft Word and ExcelAbility to follow company procedures, work instructions, and policiesWork in a safe manner; properly handle materials and chemical Excellent attention to detail and organizational skillsAbility to multi-task and prioritize work tasks with minimal supervisionExcellent interpersonal, verbal, and written communication skills Preferred:Prior experience with use of an electronic document management system in a regulated environmentby Jobble

Keywords: Arrowhead Pharmaceuticals, Madison , Quality Assurance Specialist, Other , Madison, Wisconsin

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