QA Computer Systems Validation Specialist

Labcorp seeks a Computer Systems Validation Specialist for its Monogram Biosciences lab in South San Francisco. The role involves managing validation activities, designing test protocols, and performing equipment qualification across laboratory systems in a regulated environment. This is a full-time, onsite position.

Responsibilities

• Manage IT change control system and coordinate validation activities across IT, business, and quality groups
• Design and execute test plans and test cases with stakeholders and subject matter experts
• Perform equipment qualification (IQ, OQ, PQ) on laboratory instruments and assess software validation requirements
• Execute protocols, report exceptions, and participate in exception resolution and analysis
• Support software project teams with validation requirements and compliance guidance for regulated activities

Requirements

• Bachelor's degree in Information Technology, Computer Science, Biological, or Clinical Laboratory Science
• 2+ years performing computer validations in quality assurance
• 1+ year experience in regulated environments such as Part 820, ISO 13485, GxP, CAP, or CLIA
• Strong written and verbal communication skills with excellent documentation ability
• Technical understanding of clinical laboratory operations and cross-functional collaboration

Compensation: $115,000 - $135,000 / year