Senior Laboratory Quality Assurance Manager

Stefanini, Inc; Portland (OR); On-site; USD 90,000 - 120,000; Full time

Job summary

Stefanini, Inc. is seeking an experienced Quality Assurance Manager to lead and maintain the Quality Management System for an established analytical laboratory in Oregon.

The role ensures compliance with ISO/IEC 17025, GLP, and related standards, overseeing audits, CAPA, documentation, and continuous improvement. The ideal candidate combines strong scientific grounding with hands-on QA in a regulated lab, coordinating with leadership and technical teams to uphold quality and regulatory

Qualifications

• Minimum 2+ years of QA experience in a regulated laboratory environment.
• Experience with ISO/IEC 17025, GLP, NELAC/TNI or comparable standards.
• Strong technical writing and SOP/documentation skills.
• Ability to interpret regulations and accreditation requirements.

Responsibilities

• Lead and maintain the Quality Management System (QMS).
• Manage quality documentation, SOPs, training records and controlled records.
• Coordinate internal audits and support external audits and inspections.
• Oversee CAPA processes, root-cause analysis and corrective actions.
• Maintain calibration schedules and verify equipment readiness.
• Prepare regulatory and client-facing reports and data packages.
• Communicate quality updates and improvements to leadership and teams.

Skills

Analytical thinking

Investigative skills

Problem solving

Technical writing

Microsoft Office

Regulatory interpretation

Audit experience

Education

Bachelor's degree in Chemistry or related scientific discipline

Job description

Stefanini, Inc. is seeking an experienced Quality Assurance Manager to lead and maintain the Quality Management System for an established analytical laboratory in Oregon.

The role ensures compliance with ISO/IEC 17025, GLP, and related standards, overseeing audits, CAPA, documentation, and continuous improvement. The ideal candidate combines strong scientific grounding with hands-on QA in a regulated lab, coordinating with leadership and technical teams to uphold quality and regulatory