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Quality Analyst (R1014911) in Wayne, PA at IQVIA™

Date Posted: 4/3/2018

Job Snapshot

  • Employee Type:
  • Location:
    Wayne, PA
  • Experience:
    Not Specified
  • Date Posted:
  • Job ID:

Job Description

 Summary of Essential Job Functions

  • Review and approve SOPs, Work Instructions, SDLC deliverables including requirements, test protocols, defect reporting, plans and reports by partnering with key stakeholders.
  • Approval of end-to-end testing activities including reviewing development, testing, defect reporting and closure, and summary reports to ensure objectives and compliance requirements are met.
  • Author planning, gap assessment, requirements and other SDLC documents as needed by partnering with key stakeholders to ensure defined business needs are met and in accordance with Quality Standards
  • Provide Quality Management support during SDLC activities. Participate as needed in scrum meetings and development planning.
  • Ensure requirements and processes comply with company global quality Management System policies and SOC 1 and SOC2 controls.
  • Support and coordinate internal and client audits for the payments organization
  • Provide guidance and support with remediation activities.
  • Author Corrective and Preventive Actions (CAPAs) for the payments organization  
  • Monitor and support Continuous Improvement Activities
  • Other duties as assigned

Supervisory Responsibilities

This position does not have supervisory responsibilities

Minimum Experience Requirements

  • Bachelor’s Degree in IT, Business, Accounting, Finance or related area
  • Strong knowledge of software testing and SDLC processes
  • Experience with Pharmaceutical, Clinical Trial, and/or Financial Software Quality Management activities including:
    • reviewing and approving quality deliverables of the SDLC process including user requirements, risk assessment, testing protocols
    • reviewing and approving SOPs, Work Instructions.
    • JIRA or other Agile Scrum management system
    • coaching team members on quality policies and practices
  • 3-5 years working in quality assurance/management in a regulated industry.  SSAE16 or 21 CFR Part 11 experience is preferred.
  • Previous quality process training experience is preferred.
  • Previous participation in audits is preferred.

Skill Requirements

  • Confident organized and detail oriented self-starter
  • Ability to organize and present information in clear and concise formats
  • Excellent problem-solving skills
  • Exceptional collaboration and listening skills required
  • Ability to quickly learn new concepts and tools is necessary
  • Strong written and oral communication skills
  • Ability to work independently in a global team environment to meet aggressive deadlines

Job ID: R1014911