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GxP Systems Analyst

Job Post Index 22532E-Sy##
Location Carlsbad, CA
Description: Description
  • Serves as a GxP Systems subject matter expert and provides guidance to the functional team and end users.
  • This role will translate business needs into maintainable configurations, extensions and customization's of the Mirth Connect and associated Enterprise Application systems, which may include LIMS, in a GXP compliant manner.
  • Responsibilities include the Design/Configuration of GxP System applications to support enhancement efforts and provide production support through the functional team.
  • Lead the development of applications, such as Mirth Connect, for data management and integration with Sponsors data needs
  • Works in a GMP/GCP/GLP/CLIA regulated environment and is responsible for following all applicable regulations
  • Configure LIMS to meet end-user needs and those of the clinical trial partners.
  • Work in conjunction with end-users to identify and determine operational objectives/system functionality.
  • Gather specifications, design workflow charts and diagrams, study system capabilities, identify and develop solutions to meet business and compliance needs.
  • Maintain system and operational policies and procedures in alignment with Quality best practices.
  • Perform program configuration/modification and set-up activities on projects according to established procedures.
  • Maintain laboratory GxP systems with all requirements and manage Standard Change Requests.
  • Coordinate with functional team for all activities related to GxP Systems configuration, implementation, control, and customer support.
  • Write technical and validation documents such as URS, IQs, OQs, and SOPs
  • Ensuring that Quality Events such as incidents and deviations are properly documented, and for supporting/owning the immediate remediation and preventative actions
  • Ensuring change requests are properly initiated, completed, and approved prior to the use of the assay, system, instrument, software, etc. being changed
  • Maintaining up-to-date training records and ensuring training is complete prior to performing specific job functions
  • Following approved and effective procedures to perform specific job functions, and ensuring procedures accurately reflect activities being performed
Skills: Qualifications
  • Bachelor’s Degree in a related scientific field or computer science/IT/MIS with a minimum of 5 years relevant experience required
  • Preferred minimum of 2 years of experience in a clinical trial or pharmaceutical setting.
  • Experience in Mirth Connect v3.2.2 or higher
  • Experience in supporting computer systems and maintaining compliance in a regulated environment.
  • Computer systems validation experience required.
  • Demonstrated experience with technical design, configuration and implementation of computerized Laboratory Systems, such as LIMS and Mirth, in a GxP environment.
  • Working knowledge of SQL, XML, JSON, Java, and JAVAscript programming and scripting skills preferred.
  • Required Skills:
    • Clinical Trial
    • Customer Support
    • Laboratory
    • Scripting
    • SOPS
    • Systems Analyst
    • Technical Design
    • CLIA
    • Data Management
    • Enterprise Application
    • GCP
    • GLP
    • GMP
    • Integration
    • Integrator
    • Java
    • Remediation
    • Subject Matter Expert
    • Training
    • Translate
    • Workflow

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