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    Quality Assurance Specialist - Chicago, United States - Katalyst HealthCares & Life Sciences

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    Description
    Responsibilities:
    • Responsible for performing validation of computer systems, process automation, equipment, utility systems, and/or facilities by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements including GAMP5.
    • Executes test plans according to approved procedures, collects samples, tabulates test results, and organizes data packages.
    • Compiles and analyzes validation data, prepares reports and makes recommendations for changes and/or improvements.
    • May also investigate and trouble-shoot problems which occur and determine solutions.
    • Coordinates and executes validation change control and preparation of draft protocols, reports and data tables.
    • Maintains all documentation pertaining to validation.
    • Will assist in developing procedures and/or protocols.
    • Coordinates contract personnel through completion of assignments.
    • Participates on cross-functional project teams with the support of Development, Manufacturing, Engineering, Quality, and other groups as required.
    • Previous experience with Computer System Validation (CSV) and experience with System Development Life Cycle of automated computer systems.


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