IRT Test Analyst - Clinical QA & Compliance Expert

Sharp Services, LLC; Bethlehem (Northampton County); On-site; USD 70,000 - 90,000; Full time

Job summary

Sharp Services, LLC is seeking an IRT Test Analyst in Bethlehem, PA to design and execute test plans for the IRT System and project-specific configurations. You will document and track errors through resolution and serve as SME for software testing within regulated environments.

Ideal candidates have a degree or equivalent experience, 3+ years in CRO/pharma testing, and knowledge of HIPAA, GDPR, and 21 CFR Part 11. The role requires strong communication and QA process involvement.

Qualifications

• Bachelor’s degree or equivalent work experience.
• 2-3 years’ experience in a quality management or testing role.
• 3+ years’ experience in CRO/pharma clinical research with IRT, EDC, or ePRO systems.
• Knowledge of HIPAA, GDPR and 21 CFR Part 11.
• Familiarity with GAMP 5 and regulatory documentation practices.

Responsibilities

• Write and execute test plans and test cases for IRT System configurations.
• Document and track system/configuration errors through resolution.
• Create testing summaries and coordinate with the Project Manager on resolutions.
• Communicate testing status to project team and maintain testing documentation.
• Assist in audits, regulatory investigations, and quality events as defined by SOPs.

Skills

Software testing

Communication

SQL

XML Web services

SFTP

SAS

Microsoft Office

Education

Bachelor’s degree or equivalent

Tools

Jira

Job description

Sharp Services, LLC is seeking an IRT Test Analyst in Bethlehem, PA to design and execute test plans for the IRT System and project-specific configurations. You will document and track errors through resolution and serve as SME for software testing within regulated environments.

Ideal candidates have a degree or equivalent experience, 3+ years in CRO/pharma testing, and knowledge of HIPAA, GDPR, and 21 CFR Part 11. The role requires strong communication and QA process involvement.