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Quality Systems Analyst

Location: Raritan, New Jersey Salary: Negotiable
Sector: Engineering Type: Contract

Real Staffing are looking for a Quality Systems Analyst for a 6 month contract role (pending extension) based in Raritan New Jersey.

Please read the job description and experience sections carefully and apply accordingly.

Job description:

  • 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 testing.
  • Review computerized systems validation documents such as:
    • Risk Assessment
    • Compliance Plan
    • Requirements Specification
    • Design Specification
    • Test Plans
    • Pre/Post Executed Test Scripts
    • Test Summary Reports
    • Data Migration Plan
    • Traceability Matrix
    • Compliance Report
    • Release to Production Statements
  • Manage 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.
  • Facilitate the Computer system Validation Risk Assessment to identify governing regulations and validation deliverables during the development of the computer system.
  • 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 Compliance Plans and Summaries.

Education & Experience:

  • 3 to 5 years' experience.
  • Apply FDA, MHRA, and other applicable global health authority regulations to the development of computer systems supporting regulated business processes.
  • Knowledge of 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.
  • Knowledge of IBM Rational Testing Tool.
  • 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. OpenText, Qumas, SharePoint etc.); application development and lifecycle management (e.g. PLM); 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.

Sthree US is acting as an Employment Business in relation to this vacancy.