Compliance Team, Inc.

  • Computer Systems Validaton Analyst

    Job Locations US-MO-St. Louis
    Posted Date 3 weeks ago(6/28/2018 11:51 AM)
    ID
    2018-1237
    # of Openings
    1
    Category
    Validation
  • Overview

    Compliance Team, Inc. is a leading provider of technical consulting services to our clients in the pharmaceutical, biotechnology, and medical device industries in the areas of commissioning, qualification, validation and regulatory compliance.  We are proud of our talented professionals and the major contributions they make to our clients’ successes on mission critical projects.

     

    This IT Systems Quality and Compliance role will take direction from a Team Leader to support and enhance the quality and compliance operations posture for an IT department. This includes authoring solution development lifecycle documents (SDLC) including user requirements specifications, detailed design and configuration specifications, test plan, test cases, test strategy, change control, and decommissioning plans.  This role is also expected to assist in continuous quality systems improvement for this local IT department that interfaces between a set of local site pharma/device manufacturing quality standards and a set of global IT quality standards.  Role will work on operations support (User Account Reviews, Periodic System Reviews, Change Controls) and projects support for these types of systems:  laboratory, manufacturing, environmental, quality support, configuration management.  

    Responsibilities

    • Provide technical and compliance expertise to write SDLC documentation in accordance with local procedures, templates, regulatory requirements (21 CFR Part 11, 211, 820), and IT Security Standards. Track and execute computer system Periodic Reviews, User Account Reviews, and other computer system compliance processes as assigned.
    •  Provide technical and compliance expertise to support the continuous improvement of BT Departmental operating procedures and processes.
    • Assist in performing change control impact assessments and work with technical subject matter experts (SMEs
    •  Represent Meridian IT in site level change control meetings

    Qualifications

     

    • Bachelor’s degree in Computer Science, Information Technology or other science-related discipline 
    • Proficient in English
    •  3+ years of experience in pharma/device or other regulated industry
      Excellent knowledge in writing Validation Documents (e.g. Validation Master Plans, Validation Protocols, Associated SOPs, Part 11 Risk Assessments, Verification Plans, Test Scripts).
       
    • Must have demonstrated capability in completing projects according to prescribed timelines and other requirements in previous project management or business analyst roles. 
    • Solid work ethic with a positive attitude; excellent listener, with good verbal and communication skills. 
    • Excellent self-management, time management, and problem solving skills; must be able to multi-task / multi-project. 
    • Familiarity with lab systems, plant manufacturing systems, Document Management Systems, CAPA processes, Learning Management Systems, highly desirable. 
    • Be able to function in multidisciplinary teams, must possess excellent documentation, presentation, training and computer skills. 
    • Experience with SDLC and other IT project management methodologies; Agile development is a plus. 
    • Lean Six Sigma certification and/or experience preferred 
    • NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS:
      Travel between St. Louis locations will be required.

      NOTE: ITEMS IN BOLD ARE THE MUST HAVE ITEMS.

     

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