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    Business Analyst - Philadelphia, United States - Saxon Global

    Saxon Global
    Saxon Global Philadelphia, United States

    2 weeks ago

    Default job background
    Description
    Business Analyst Address the work will be performed: Hybrid Philadelphia PA Target start date: 4/3 Length of contract assignment: 8 months Work schedule/typical work week/daily start and end time:

    • 40 hours, Mon-Fri
    • 8am to 5pm Onsite at the Philadelphia location 3 days/week Visa:

    All Rate:
    $75/hr C2C Client description:

    • Medium sized Biotechnology company that focuses on Cell & Gene Therapies
    • Provides R&D and Manufacturing services.
    • IT Organization is going through some changes and will now be aligned through Facilities leadership.
    • Multiple high priority IT projects in 2023 in preparation for onboarding of new client, Johnson and Johnson

    Project description:

    • Client is looking for a senior BA with GxP regulated Lab Applications/Systems experience.
    • Manage MES workstream for Implementation of a new platform
    • Will be responsible for analyzing lab apps (Discover, Documentation, Workflow) and developing the lifecycle management plans.
    • Project champion for migration of Blue Mountain RAM CMMS to the cloud
    • Engage with stakeholders on the environmental monitoring project to perform gap analysis of environmental monitoring software.
    • Support regulatory and compliance team on the migration of document management system from local version 1 to enterprise version 5.
    • Work with stakeholders and manage the examination of current lab systems and applications and determine if they are a fit for intended purposes.
    • Organize workflows and ownership of all systems currently in place.
    • Provide recommendations/guidance on which systems/applications are non-core.

    Consultant's day to day responsibilities:

    • Participate in GxP validation activities (writing and reviewing protocols)
    • Discovery activities including interviewing stakeholders, SME's, vendors/suppliers.
    • Developing SOP's, training documentation, test plans and test cases.
    • Act as additional resource for current BA team supporting priority projects.
    • Lead work sessions, focus groups and vendor workshops to capture clear user requirements.
    • Work with business stakeholders to define expected outcomes and establish KPI's

    Required Skills:

    • Prior Experience as Business Analyst in the Pharma IT space, must have: o Experience in GxP, 21 CFR Part 11 environment o Served as the lead BA on a full life cycle implementation project. o Served as BA on an MES project Desired Skills
    • EBR, ELN project experience preferred.
    • Served as a BA on Building and Manufacturing Applications (Ex: Rees Scientific, ELPRO and Empower CDS.)
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