Software Quality Analyst

@ Clinical ink

Company Information

Clinical ink is a global life science company that brings data, technology, and patient science together to unlock clinical discovery. With deep therapeutic expertise and innovative digital solutions such as Direct Data Capture, eCOA, eConsent, telehealth, neurocognitive testing, and digital biomarkers, Clinical ink is rewriting the clinical development experience with offices in Philadelphia, PA, Winston Salem, NC, and Iowa City, IA.

Job Description

Clinical ink is seeking a Software Quality Analyst to join our Product Quality team. This position is based remotely across the United States and involves ensuring that all development validation deliverables comply with SOPs, Guidelines, and FDA regulations.

Responsibilities

• Develop validation deliverables including Validation Plans, Validation Summary Reports, and Test Cases.
• Collaborate with Development Services to create effective testing strategies for the SureSource platform.
• Manage test plan execution, including executing test cases and documenting defects through resolution.
• Ensure compliance with internal controls and FDA regulations.
• Assist with Study Quality testing activities as needed and perform other related duties.

Qualifications

• Bachelor’s degree or relevant industry experience.
• High achieving with an exploratory nature and a desire to learn and grow.
• Strong work ethic, sense of ownership, and pro-active attitude.
• Effective prioritization, time management, communication, and analytical reasoning skills.
• Attention to detail is essential.

Additional Information

Clinical ink is an equal opportunity employer. We do not discriminate based on race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability, or veteran status.

Key skills/competency

• Validation
• Testing
• FDA
• SOP
• Quality Assurance
• Compliance
• Defect Tracking
• Collaboration
• Analytical Reasoning
• Attention to Detail