• Systems Analyst

    Posting Date 4 weeks ago(10/17/2018 2:40 PM)
    Requisition ID
    2018-5520
    Job Location(s)
    Pittsburgh PA United States
    Position Type
    Full Time
    Company
    Cook Myosite Inc.
    Category
    Information Technology
  • Overview

    Cook MyoSite Incorporated, a division of Cook Incorporated, is a growing, forward-thinking biotechnology organization seeking a full time Systems Analyst.  In a highly regulated environment, the System Analyst provides technical subject matter expertise and is responsible for operational ownership of application systems providing business/IT or manufacturing support (i.e. CRM, ERP, eQMS, HRIS).  provides technical subject matter expertise and is responsible for operational ownership of application systems providing business/IT or manufacturing support (i.e. CRM, ERP, eQMS, HRIS).

    Responsibilities

    • Serve as system owner for applications for the duration of a Systems Development Lifecycle (SDLC), having responsibility for the delivery, integration, modification, maintenance, and retirement of the application
    • Work with Business Analysts to:
      • Define technical project scope and requirements
    • For new systems or updates to existing systems author:
      • Application functional specifications
      • Configuration and data mapping documents
      • Commissioning documents (i.e. unit tests, software verification tests)
    • Support the delivery of enterprise applications and solutions by either:
      • Configuration of parameters and workflows to define COTS application behavior
      • Or programming (i.e. C#, SQL, Python, etc.) to extend the capabilities of a COTS application
    • Lead application demonstrations and work with end-users to insure user requirements are met
    • Actively participate in risk assessments and various review meetings supporting application delivery
    • Maintain professional and technical knowledge by attending educational workshops; benchmarking state-of-the-art practices; participating in professional societies
    • Execute commissioning; support validation team’s installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities
    • Function as an application level system administrator
    • Create and review Standard Operating Procedures (SOPs) and training materials; conduct training for SOPs
    • Develop reporting tools to support quality, including configuration to support data trending and analysis
    • Must maintain company quality and safety standards
    • Ensure data integrity of existing systems by monitoring system performance and data metrics
    • 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

    Qualifications

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

    • 3+ years of software application experience in one or more of Applications Engineering or Configuration, Applications Delivery, Software Development, Software Requirements Analysis, Information Analysis, or Software/IT Support Experience developing solutions in enterprise class IT systems with applications such as CRM, ERP, eQMS, HRIS

    • 3+ years using MS Word, Excel and Visio or equivalent

    • Excellent interpersonal and communication skills, both written and verbal

    • Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with supervision
    • Potential to understand of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical/Med product manufacturing and best practices (e.g. ISPE GAMP)
    • 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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