Quality Assurance Systems Specialist, Validation and Data Integrity

Job overview

The Quality Assurance Systems Specialist role is onsite in Bend, OR. Compensation is not specified. The position supports site quality activities involving equipment, analytical instruments, and computerized systems. The specialist helps maintain compliant, validated systems and strengthen data integrity practices across the site. By coordinating with IT, QC, Automation, QA, and vendors, the role supports qualification and validation work, inspection readiness, investigations, and corrective and preventive actions.

What you'll do

• Support commissioning, qualification, and computer system validation projects
• write, execute, review, and approve validation protocols, reports, and lifecycle documents
• perform change and risk assessments
• serve as a subject matter expert for validation strategy
• troubleshoot systems and support staff training
• participate in inspections, investigations, root cause analysis, and CAPAs
• promote data integrity awareness and maturity
• facilitate data integrity forums and walkthroughs
• generate, review, and approve controlled documents and records
• supervise validation activities and help resolve problems.

What we're looking for

Skills & competencies

quality assurance systems specialist

validation

data integrity

bend or

katalyst healthcares & life sciences

equipment qualification

computerized systems validation

gxp

21 cfr part 11

capa

pharmaceutical biotechnology

Work arrangement

• Weekend coverage required

Why this role

Focus on equipment and analytical instrument qualification, computerized systems validation, and data integrity under GxP, 21 CFR Part 11, Annex 11, and USP standards.

About the employer

Katalyst Healthcares & Life Sciences is hiring for this role. Industry: Research and Development in Biotechnology (except Nanobiotechnology). Sector: 54.