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QA Specialist III (Shift 5)

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POST DATE 8/19/2016
END DATE 10/16/2016

MedImmune, LLC Boulder, CO

Company
MedImmune, LLC
Job Classification
Full Time
Company Ref #
360208
AJE Ref #
575927580
Location
Boulder, CO
Experience
Entry Level (0 - 2 years)
Job Type
Regular

JOB DESCRIPTION

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When shift operations begin, this role will work 5th shift; Saturday to Monday, 1900 to 0730. br * Utilizes quality assurance system in compliance with current good manufacturing practice regulations and corporate policies and procedures. br * Supports the evaluation and disposition of labeling, raw materials, intermediates and finished products through timely compliance evaluation of batch records, laboratory results and other cGMP documents. br * Supports identification of root causes, recommends and implements corrective actions to prevent recurrence. br * Performs trend analysis to monitor process and facility performance. Employs metrics to track the performance of operations and quality systems. br * Supports audits of manufacturing, analytical testing, contractor/supplier or labeling areas to ensure compliance with SOP and regulatory requirements per the requirements of the self-inspection program. Provides leadership and guidance to peers in the QA department and functional areas. br * May assist in the training activities of other QA personnel. br * Assists with coordination of the self-inspection program and conducts audits as required. Assists with the coordination of the inspection readiness program and with any site audits. br * Manages workflows to assure timely supply of product. br * Administers the change control and Deviation and corrective action systems for assigned products and quality systems. p /p ~bsp p /p