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QA System Administrator

Company: Precise Solutions
Location: Sunnyvale
Posted on: November 11, 2019

Job Description:

Precise Solutions is an Illinois BEP/FBE (female owned business enterprise) certified consulting company founded in 2000. Our mission is to provide companies with specialized resources that can drive their system portfolio projects using program management processes, change management and blended learning solutions. Please visit our website at
At Precise Solutions, we are looking for top talent consultants to bring on as employees of our organization and service our clients in the pharmaceutical and healthcare industries primarily located in the Northern Chicago Suburbs. We are much more than a consulting firm! Precise Solutions provides competitive compensation packages with great salaries, benefits, health insurance, paid time off and 401k. We currently have an immediate need for the following:
Job Title: QA Systems Administrator/ Operations AnalystClient: Pharmaceutical, TBABusiness Unit: Business Technology Solutions Finance (HQIF)Location: Sunnyvale, CaliforniaPay Rate: $50- $55 pr. Hr. plus health, dental, vision insurance, 401k and PTO
General Position Summary/Purpose: The QA Systems Administrator/Operations Analyst will plan, configure, deploy, and support QA and GMA systems including Information Request Management System (IRMS), Interactive Voice Response System (IVRS), Quality Management Systems (QMS), Trainings applications and other enterprise systems supporting core R&D functions and processes. The resource will be hands-on and will collaborate closely with Quality Operations, GMA and other R&D departments, other IT resources and our vendors. The position will work closely with the IT Operations and will report directly to the Manager, IT R&D Regulatory and QA Key Accountabilities/Core Job Responsibilities:

  • Overseeing administration of Quality and GMA systems, including user access, maintaining permissions/roles
  • Administering SharePoint (2)
  • Working with Super Users to:
  • Efficiently enter data and ensure data quality
  • Investigate system issues, performing root cause analysis
  • Evaluate options for system enhancements/process improvements
  • Planning/implementing incoming integrations with CROs, third party vendors, CIS, etc.
  • Planning/implementing reports/graphs/dashboards (Excel, SSRS, Tableau, Business Objects, etc.)
  • Evaluating requests for customization using various platforms/technologies (SharePoint, InfoPath, HTML, CSS, XML, JS, Office automation)
  • Using Microsoft Excel and other tools to analyze/process clinical operations data
  • Collaborating with the Business Owner, System Owner, IT Compliance, etc. to drive Change Control for GxP applications
  • Lead impact analysis and system testing for new releases/patches
  • Proposing validation strategy, authoring SOPs/validation protocols/test plans, etc.
  • Assisting in the creation of training materials/programsLeading in meetings with Business customers and assisting the Project Manager in generation and management of documents and reports
    • Qualifications, Experience, and Education Requirements:
      • Deep understanding of operational aspects of Manufacturing and Medical Affairs including:
      • Quality documentation and management
      • Audits and submissions to FDA and other health agencies
      • Process management for filing AE, Product complaints, etc.
      • IVRS call center workflow and call forwarding rules
      • Case report review and processing
      • Risk-Based Monitoring
      • The purpose and process of issues/protocol deviations
      • Regulatory requirements for Clinical Trials (especially in US but also familiar with worldwide health agencies)
      • Deep understanding of IT practices including:
      • Computer Systems Validation
      • GCP/GVP/GDP/ICH and Title 21 CFR Part 11
      • Change Control for GxP systems
      • Using helpdesk/ticketing systems (especially ServiceNow)
      • Good speaking/written communication skills
      • Prefer 5+ years relevant IT experience
      • Knowledge of the following is preferred:
      • VBA/MS Office Automation, Customization and Interoperability
      • PowerShell scripting
      • Database Design and Management (especially T-SQL/Oracle)
      • Data warehousing and ETL (especially Informatica and Oracle)
      • SharePoint Development (non-code)
      • InfoPath Development
      • Web technologies, e.g., HTML, CSS, Java[Script], JSON, Web Services/REST, XML/XSLT
      • Visual Studio/.Net development
      • Microsoft Office, including: Access, Word, Excel, PowerPoint, Outlook, ProjectBS in a related field.
        • Length of Contract: One year
        • Are you open to look at candidates willing to relocate? - Preferred local
        • Years of experience/education/certifcations required: 5+ years and bachelors degree
        • What are the top 3 skills/requirements this person should have?
        • Business Analyst Skills
        • Data Migrations
        • Expert level in MS Excel
        • Soft Skills?
        • Organization
        • CommunicationWritten/oral communication
          • What type of environment is this person working in? Team Setting
          • How soon after the request is published to the supplier are you looking to start interviewing: ASAP
          • Interview Process (will this be a phone or in-person interview): Phone and in person
          • Work Schedule: Flexible as long as they can support the team within an 8 hour work day.

Keywords: Precise Solutions, Sunnyvale , QA System Administrator, IT / Software / Systems , Sunnyvale, California

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