END DATE October 16, 2016

QA Specialist III (Shift 4)

MedImmune, LLC - Boulder, CO

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

Job Description

When shift operations begin, this role will work 4th shift; Saturday to Monday, 0700 to 1930. 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