• ERP Systems Analyst

    Posting Date 2 months ago(10/26/2018 2:08 PM)
    Requisition ID
    2018-5562
    Job Location(s)
    Pittsburgh PA United States
    Position Type
    Full Time
    Company
    Cook Myosite Inc.
    Category
    Information Technology
  • Overview

    In a highly regulated environment, the System Analyst provides technical subject matter expertise for application specification, configuration, and testing of enterprise computer systems at Cook MyoSite. This opportunity is to provide application delivery services for the MyoSite Sage Enterprise Management (ERP) system.

    Responsibilities

    • Work with Business Analysts to:
      • Update or create, application/software/IT use case documents and requirement specifications
      • Define technical project scope and objectives
    • Independently author:
      • Application/software/IT functional specification documents
      • Commissioning documents (i.e. unit tests, software verification tests
    • Independently provide for the delivery of modules for an ERP system by:
      • Configuration of parameters, forms, and workflows in the software to define application behavior
    • Lead application demonstrations and work with end-users to insure user requirements are met
    • Execute commissioning; support validation team’s installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities
    • Function as an application level system administrator
    • Collaborate to produce Standard Operating Procedures (SOPs) and training materials; conduct training for SOPs
    • Develop reporting tools to support quality assessment
    • Practice and stay current with ISPE GAMP best practices, FDA GxP regulations, and applicable ISO standards
    • Coordinate activities with external consultants
    • Monitor project progress by tracking activities; resolving problems; publishing progress reports; recommending actions
    • Must maintain company quality and safety standards
    • Must maintain company values

    Qualifications

    • Bachelor’s degree in Computer Science, Information Systems, or a technology based related field of study

    • 3+ years of experience in one or more of Applications Engineering or Configuration, Applications Delivery, Software Development, or Software Requirements Analysis

    • 3+ years of experience in developing and delivering software solutions for an ERP system such as provided by:  Sage, SAP, Oracle, Microsoft

    • Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with supervision

    • Able to demonstrate the experience to independently carry out tasks under the direction of MyoSite CSA staff

    • Able to demonstrate an understanding of FDA 21 CFR Part 11 and related regulations associated with biopharma, pharma or medical device industries

    • Able to demonstrate an understanding of manufacturing best practices like those described in ISPE GPGs
    • Ability to comprehend technical information related to biotech equipment, computer and network hardware, and the associated regulatory expectations relating to them

     

    Physical Requirements:

    • Must be able to physically position at desk, in meetings, and work on a computer in an office setting for long or extended periods of time

    • Physically capable of standing, walking, stooping, kneeling, climbing, reaching, twisting and bending on occasion with or without reasonable accommodation in a warehouse or laboratory setting

    • Must perform PPE procedures including, safety glasses, lab coat, gloves, and appropriate shoes on occasion
    • Must be able to at times work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours, sometimes on short notice as required
    • Ability to work under specific time constraints

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