• Systems Analyst

    Posting Date 8 months 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, Inc. is on a mission to make regenerative medicine a part of everyday medicine. We’re investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders. We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours. Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose. If you’re curious, motivated by helping others, and driven by integrity, we invite you to apply below.

    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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