Jobs
>
Princeton

    Validation Analyst - Princeton, United States - iTvorks Consulting and Development

    iTvorks Consulting and Development
    iTvorks Consulting and Development Princeton, United States

    3 weeks ago

    Default job background
    Description


    ITVorks Inc., seeks ValidationAnalysts for its Princeton, NJ office to Review documents including clinicalstudy reports, labeling drafts and validation and stability protocols andreports.

    Develop and Execute Installation, Operational, and PerformanceQualification (IQ, OQ and PQ) protocols, and prepare Test Plan and FinalValidation Report.

    Perform GAP analysis on GXP system that directly affectsproduct quality and Data Integrity and ensure all the requirements have beentested and also comply with applicable FDA Regulations.

    Prepare validation orperformance qualification protocols for new or modified manufacturingprocesses, systems, or equipment for pharmaceutical production. Prepare andsubmit of Chemistry, Manufacturing, and Controls (CMC) sections for regulatorydrugs and submissions, information amendments, supplements, and annual reports.
    Travel to various unanticipated locations in the United States to interact withclients for short or long term assignments.

    Master's Degree or foreignequivalent in Pharmacy/Regulatory Affairs/Chemistry or related + 1 yr ofexperience as Clinical Analyst, Regulatory Affairs Associate, QA Engineer orrelated, developing/creating Test Plan, and using software validation lifecycle and EDC applications (Medrio, RAVE and Inform) is required.


    Work Location:
    Princeton, NJ.

    Travel required to interact with clients & train end users.
    Pleasesend resume & cover letter indicating position and Job Code to

    .

    Human Resources,

    ITVorks Inc., 101College Rd East, Suite #302, Princeton, NJ

    #J-18808-Ljbffr


  • QuidelOrtho Raritan, United States

    The Opportunity · QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are mo ...


  • Thermo Fisher Scientific New Brunswick, United States

    Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission - to enable our customers to make the world healthier, safer, and cleaner. · Within our Anal ...


  • Thermo Fisher Scientific New Brunswick, United States

    Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission - to enable our customers to make the world healthier, safer, and cleaner. · Within our Anal ...

  • Omni Inclusive

    Validation Analyst

    3 weeks ago


    Omni Inclusive Far Hills, United States

    Lifesciences industry experience is mandatory · • Comfortable with Software Development Lifecycyle in Life Sciences industry. · • Ensure full adherence to Agile framework and the Software Development Lifecycle · • Management working closely with the Product owners, Scrum Masters ...

  • Omni Inclusive

    Validation Analyst

    3 weeks ago


    Omni Inclusive Far Hills, United States

    Lifesciences industry experience is mandatory · • Comfortable with Software Development Lifecycyle in Life Sciences industry. · • Ensure full adherence to Agile framework and the Software Development Lifecycle · • Management working closely with the Product owners, Scrum Maste ...

  • Insight Global

    Validation QA Analyst

    4 weeks ago


    Insight Global Rahway, United States

    Job Title: · Computer System Validation QA Analyst · Duration: · 6-9 month contract, possibility for extensions · Location: · Hybrid onsite 3 days per week in Rahway, NJ, 2 days remotely from home · Qualifications: · B.S. and/or M.S. degree in an appropriate Life Science, Com ...


  • Thermo Fisher Scientific New Brunswick, United States

    Job Description · Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission - to enable our customers to make the world healthier, safer, and cleaner ...


  • Thermo Fisher Scientific New Brunswick, United States

    Job Description · Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our customers to make the world healthier, safer, and cleaner. ...

  • Tekshapers Inc

    ERP Analyst

    2 weeks ago


    Tekshapers Inc Princeton, United States

    Job Summary · ERP Analyst coordinates the planning and implementation of the Enterprise Resource Planning system to align with business initiatives. Responsible for working with internal customers in identifying information opportunities and practical solutions using existing or ...


  • Munich Re America Services Princeton, United States

    Expense & Budget Analyst · **Company** · Munich Re America Services · **Location** · Princeton, United States · **Expense & Budget Analyst** · We're adding to our diverse team of experts and are looking to hire those who are committed to building a culture that enables the creati ...


  • Princeton Plasma Physics Laboratory Princeton, United States

    Overview: · The lead design analyst for assigned NSTX-U modification and/or design change tasks reports to and receives functional direction from the PPPL Engineering Department and is matrixed to the NSTX-U Recovery Project; the NSTX-U Project Engineer provides project direction ...

  • Zycus

    Solutions Consultant

    3 weeks ago


    Zycus Princeton, United States

    **About Us** · Zycus is a pioneer in Cognitive Procurement software and has been a trusted partner of choice for large global enterprises for two decades. Zycus has been consistently recognized by Gartner, Forrester, and other analysts for its Source to Pay integrated suite. Zycu ...

  • Cybotic System

    ERP Analyst

    1 week ago


    Cybotic System Princeton, United States

    _**Must-Haves**:_ · Minimum Relevant Experience: 2 years experience Must have experience with ERP and ERP-based financial reporting tools SQL, SSRS, and Power BI experience · Education/qualification: Bachelor's degree or relevant experience. · - **Nice to Haves**:_ · Experience v ...

  • Cybotic Systems

    ERP Analyst

    1 week ago


    Cybotic Systems Princeton, United States

    **Job Summary** · **ERP Analyst **coordinates the planning and implementation of the **Enterprise Resource Planning system** to align with business initiatives. Responsible for working with internal customers in identifying information opportunities and practical solutions using ...

  • Mindsgroup Infotech LLC

    Business Analyst

    1 week ago


    Mindsgroup Infotech LLC Princeton, United States

    Looking for fresher/ experience BA consultants for our direct client requirement. Consultants should must have bachelor's degree & must have excellent English communication & writing skills. · Position**:Business Analyst (On - Site)** · Location: New York/ New Jersey · Duration : ...


  • Princeton University Princeton, United States

    Overview: · The Center for Statistics and Machine Learning is hiring a Computational Research Analyst to perform research on aggregated decision-making through rule systems with includes research into electoral mechanisms including the Electoral College, redistricting, and voting ...


  • NRG Princeton, United States

    As an NRG employee, we encourage you to take charge of your career and development journey. We invite you to explore exciting opportunities across our businesses. You'll find that our dynamic work environment provides variety and challenge. Your growth is key to our ongoing succe ...

  • Groupsoft Us Inc

    SAP Testing Lead

    6 days ago


    Groupsoft Us Inc Princeton, United States

    **Title**: SAP Testing Lead · **Location**: Princeton, NJ · **Company**: GROUPSOFT · **Employment Type**: · - Full Time Employment · **COMPANY DESCRIPTION** · Groupsoft US Inc. is a Software Service company providing end-to-end Consulting and implementation services to large Reta ...


  • Epsom Global Consulting Plainsboro, United States

    **Job Overview**: · We are seeking a talented QA Analyst with expertise in Marketing Cloud softwares similar to Salesforce Marketing Cloud or Adobe Campaign to join our growing team. If you are passionate about quality assurance, have a keen eye for detail, and possess strong ski ...

  • Novo Nordisk

    Business Analyst Ii

    2 weeks ago


    Novo Nordisk Plainsboro, United States

    **About the Department** · The Finance and Operations dept. brings insights and intelligence to inform decision making & drives digitalization and business solutions to attain NNI goals. Finance and Operations works closely across the organization to guide enterprise-wide resourc ...