[Remote] Quality Assurance Engineer

Note: The job is a remote job and is open to candidates in USA. Katalyst CRO is seeking a QA Engineer with experience in the Life Sciences domain to support testing and validation in a regulated environment. The role involves developing and executing test cases, ensuring compliance with regulations, and collaborating with cross-functional teams.

Responsibilities

• Develop & execute manual and automation test cases
• Perform functional, regression, and integration testing
• Log and track defects using JIRA or similar tools
• Ensure compliance with GxP, FDA, and 21 CFR Part 11 regulations
• Collaborate with cross-functional teams in an Agile environment

Skills

• 10+ years of experience in QA / Testing
• Experience in Life Sciences / Pharma domain
• Strong knowledge of GxP, FDA regulations
• Hands-on with Selenium or automation tools
• Experience with JIRA or similar tools
• CSV (Computer System Validation) experience
• API Testing (Postman)
• Basic SQL knowledge

Company Overview

Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide. It was founded in undefined, and is headquartered in South Plainfield, New Jersey, USA, with a workforce of 51-200 employees. Its website is http://katalysthls.com.

Company H1B Sponsorship

Katalyst CRO has a track record of offering H1B sponsorships, with 3 in 2026, 37 in 2025, 14 in 2024, 24 in 2023, 52 in 2022, 54 in 2021, 39 in 2020. Please note that this does not guarantee sponsorship for this specific role.