Lead Software Quality Analyst

Clinical Ink
7 April 2021


Company Description
Clinical Ink is a global clinical trial technology company that is transforming the clinical trial experience. Founded in 2007, the Company’s proven and future-built eSource platform, which includes solutions for EDC replacement, eCOA, ePRO and more, accelerates time to value while delivering scientific results that matter. With offices in Winston-Salem, NC, and Philadelphia, PA, Clinical Ink is advancing the business model responsible for bringing new treatments to market.

Job Description
Clinical Ink is seeking a Lead Software Quality Analyst to join our Development team! The candidate will be responsible for developing testing strategies, creating validation documents, and managing validation deliverables. The ideal candidate will have at least 6 years of hands-on software QA experience combined with at least 2 years working as a lead. The Lead Software Quality Analyst's responsibilities include:
  • Serve as lead quality contact for the designated product:
    • Work with the Development team and Product Management teams to develop testing strategies and scenarios to effectively qualify Clinical Ink’s next gen platform(s).
    • Liaise with appropriate project team members for follow-up, resolution, and closeout of qualification and validation activities.
  • Leads and performs risk-based validation of GxP systems, develops validation documents using defined SOPs processes, and communicates project progress throughout the system lifecycle.
  • Manage the hands-on creation and approval of validation deliverables according to SOPs including, but not limited to:
    • Validation Plans
    • Validation Summary Reports
    • Release Risk Assessment
    • Traceability Matrix
  • Coordinate and manage test plan execution by:
    • Managing test case execution
    • Executing test cases
    • Documenting defects and tracking through to resolution
  • Ensure all validation activities and deliverables comply with internal controls and FDA regulations.
  • Work closely with IT, QA, and/or third-party vendors to create Development, Test, Production environments at the right timing for testing.
  • Utilize advanced hands-on experience to build automated regression testing capabilities using current technologies for web and mobile.
  • Review other team member's work and hold other team members accountable for high-quality software.
  • Maintain and communicate QA-related risk to Project Management.
  • Maintain and communicate QA metrics to internal stakeholders via status/metrics reports.
  • Perform other related duties as assigned.
  • Bachelor’s degree or relevant industry experience.
  • 6+ years of hands-on Software Quality Assurance experience with 2+ years of testing consumer mobile apps.
  • 2+ years as Lead Quality Assurance.
  • Experience with automation tools such as Selenium and Appium.
  • Experience with Browser testing and mobile testing tools, such as LambdaTest or BrowserStack.
  • Strong attention to detail and quality-oriented.
  • System lifecycle (SLC) experience in a regulated environment.
  • Ability to coordinate cross-functional work teams towards task completion.
  • Exceptional communication skills.
  • Technically hands-on, can help diagnose issues or explain the detail behind a bug report.
  • Sense of ownership and proactivity.
  • Effective prioritization and time management.

Additional Information
Clinical Ink is an equal opportunity employer and does not discriminate against otherwise qualified applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or handicap, or veteran status.

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