September 11, 2016

Senior Analyst - QCIS

MedImmune, LLC - Frederick, MD

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

Job Description

*Performs day-to-day administration activities of QC computerized systems, primarily LabWare LIMS. br *Builds LIMS master data, and reviews data built by junior LIMS Administrators. br *Contributes to the continuing expansion and evolution of LabWare LIMS as a Subject Matter Expert. br *Trains and assists junior LIMS Administrators. br *Writes/reviews LIMS change requests. br *Acts as the liaison between the various user groups which interface with LIMS such as Microbiology, Biochemistry, Materials Management, Manufacturing, Raw Materials, and Quality Assurance. br *Acts as the liaison with Information Technology to support activities related to maintaining LabWare LIMS. br *Trains new and existing LIMS users, prepare training materials as necessary. br *Writes/reviews deviations and CAPAs related to LabWare LIMS. br *Creates/Revises SOPs related to LabWare LIMS and supporting business processes. br *Supports LIMS interface with other enterprise systems such as SAP. br *Monitors LIMS to ensure compliance with regulatory requirements, in particular 21 CFR Part 11, and Annex 11. br *Identifies improvement opportunities where LIMS is involved, and assists in driving the implementation of new processes in his/her functional area. br * Maintains up to date knowledge of all applicable corporate and regulatory guidelines with respect to his/her functional area. br * Coordinates with other departments (such as QA, QC and IT) to gather all required information and documentation in relation to process improvement, implementation and/or investigations. br * Represents QC, as needed, during meetings, communicates and tracks all follow-up items through to completion. p /p ~BSP p /p