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Validation Specialist

Company: Experis
Location: Princeton
Posted on: March 18, 2023

Job Description:

Validation Specialist - Our client in (Princeton, NJ) is looking for hardworking, motivated talent to join their team. (Validation) Don't wait--- apply today! What's in it for you?

  • Hybrid - Onsite as well as Remote
  • Contract or Permanent
  • Full time or Part Time
  • (Add 1-2 other key selling points Ex: Opportunity for growth, on public transportation, etc.)Job DescriptionLocation: Princeton, NJ (Nassau Park). The candidate must be able to work onsite 50% of the time at Nassau Park, Need localsDuration: 4 months with the possibility of extension/conversionCandidates Must Be Fully VaccinatedMust-Have Requirements:
    • 2+ years of experience in managing the projects as CSV specialist /lead
    • 2+ years of experience in testing , (script reviewing from a QA perspective in particular )
    • 2+ years of experience in authoring , reviewing various validation documentation such as (Val plan , Risk assessments etc.)
    • Good communication and writing skills
    • Data Integrity experience is a plusSkills:
      • Application lifecycle management (ALM) Software: 3-5 yrs
      • Change Management: 0-2 yrs
      • Computer System Validation: 3-5 yrs
      • CSV: 3-5 yrs
      • 2+ years experience
      • Apply FDA, MHRA, and other applicable global health authority regulations to the development of computer systems supporting regulated business processes
      • Follow SOPs and industry best practices
      • Possess Expertise on Good Documentation and Good Testing Practices, in order to train those within the business that are less familiar.
      • Facilitate the Computer system Validation Risk Assessment to identify governing regulations and validation deliverables during the development of the computer system
      • Review validation deliverables for projects which are contracted to third party suppliers
      • Maintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues
      • Assist in planning, implementing, and documenting user acceptance testingReview computerized systems validation documents such as:
        • Requirements Specification
        • Design Specification
        • CSV Risk Assessment
        • Test Plans
        • Test Summary Reports
        • Data Migration Plan
        • Pre/Post Executed Test Scripts
        • Traceability Matrix
        • Release to Production Statements
        • Direct and review testing
        • Provide guidance on quality issues that affect the integrity of the data or the system
        • Obtain and respond to QA review
        • Participate in establishing standard quality and validation practices
        • Independently assess compliance practices and recommend corrective actions
        • Approve validated computer system related change requests
        • Monitor regulatory and inspection trends and advise the business on suitable action
        • Ability to create documents to an existing document standard.
        • Able to develop all documentation required for a 21 CFR Part 11 validated project, including Validation Plans and Summaries.
        • Advanced knowledge of complete MS Office suite and Visio. Firm understanding of technology platforms as needed for project.
        • Experience with electronic document management systems (e.g. documentum, Qumas, SharePoint etc.); application development and lifecycle management (e.g. HP ALM, JIRA, etc.); and IT service management systems (e.g. ServiceNow, SAP Solution Manager, etc)
        • Excellent oral and written communication skills in English. Strong expertise and ability to interview and accurately interpret communication requirements of team members.
        • Once trained, have the ability to work independently on CSV projects with minimal oversight.
        • Ability to perform in a highly matrixed organization structureWhy should you choose:
          • Medical, Dental, Vision, 401k
          • Weekly pay with direct deposit
          • Consultant Care support
          • Free Training to upgrade your skills
          • Dedicated Career Partner to help you achieve your career goalsAre you Interested? Share this job with friends and family and earn dollars with every successful hire.

Keywords: Experis, Trenton , Validation Specialist, Other , Princeton, New Jersey

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