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Business Analyst FDA Regulated Industry

A-Line Staffing Solutions

Business Analyst FDA Regulated Industry

Myrtle Point, OR
Full Time
Paid
  • Responsibilities

    Job Description

    Business Analyst Senior Associate ( Remote Opportunity )

    Fully remote - Must work in EST

    NOTE: NOT A C2C OPPORTUNITY 4 years of experience within FDA regulated industry ideally pharma or biotech Validated IS System experience is a plus Domain knowledge experience is a plus Job Details: This role functions as the liaison between functional business units and the IS organization. Must possess the skills to clearly capture and articulate the client's processes partner with the client to identify process improvement and translate strategies into information solutions. Role varies between client focused and application focused. More specifically this role will support the digital technology transfer program under Product Lifecycle Management. Skills: experience on a project team and an FDA-regulated industry pharmaceutical food cosmetics preferred

     

    Day to Day Responsibilities:: The candidate will work under the guidance of subject matter expert (SME)

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    • Work closely with business end users to develop business and functional requirements
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    • Monitor project progress by tracking the development and testing activities and report on a weekly basis.
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    • Author and Review Validation documentation
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    • Coordinate Test Management and validation activities
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    • Setup, coordinate and manage events like UAT/TAT/AAT etc.
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    • Work with business to develop training materials, WBT, GDE, etc.
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    • Other activities as assigned. Employee Value Proposition:: Digital tech transfer within process development.
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    • Skill Sets:: Experience with Agile tools (JIRA, Atlassian) - must have Business analyses Project management skills MS Teams

    SYED MATHEEN IT STAFFING MANAGER DIRECT (586) 710-7946

    CELL # 248-703-2536 matheen@alinestaffing.com