IRT Test Analyst: Clinical Systems QA

Sharp Services; Bethlehem (Northampton County); On-site; USD 70,000 - 100,000; Full time

Job summary

Sharp Services is seeking an IRT Test Analyst to design and execute test plans for the IRT System, ensuring configuration accuracy and thorough defect tracking. The role emphasizes GAMP 5 methodologies, quality systems, and cross-functional collaboration to resolve issues.

The candidate will document test results, prepare testing summaries for stakeholders, and support internal/external audits while maintaining rigorous testing documentation.

Qualifications

• Bachelor’s degree or equivalent work experience in a related field.
• 2-3 years’ experience in quality management or testing roles.
• 3+ years’ experience in CRO/pharma with IRT/EDC/ePRO systems.
• Familiarity with GCP/ICH-GCP and FDA regulations.

Responsibilities

• Write and execute test plans and use cases for IRT System functionality.
• Document and track errors through resolution and testing summaries.
• Maintain testing documentation and participate in audits.
• Collaborate with project managers to develop testing timelines and risk assessments.
• Communicate testing status to project teams and stakeholders.

Skills

SDLC knowledge

Communication

SQL

XML Web services

SFTP

SAS

Education

Bachelor’s degree or equivalent work experience

Tools

SQL

XML Web Services

SFTP

SAS

Job description

Sharp Services is seeking an IRT Test Analyst to design and execute test plans for the IRT System, ensuring configuration accuracy and thorough defect tracking. The role emphasizes GAMP 5 methodologies, quality systems, and cross-functional collaboration to resolve issues.

The candidate will document test results, prepare testing summaries for stakeholders, and support internal/external audits while maintaining rigorous testing documentation.