Quality Manager

Quality Assurance Manager

Location: Oregon Employment Type: Full-Time Department: Quality Assurance Industry: Laboratory Testing / Analytical Sciences

Position Overview

We are seeking an experienced Quality Assurance Manager to lead and maintain the Quality Management System for an established analytical laboratory in Oregon. This position is responsible for ensuring laboratory operations, documentation, testing procedures, and quality practices remain compliant with applicable regulatory requirements and accreditation standards. The Quality Assurance Manager will work closely with laboratory leadership, technical teams, and support staff while overseeing quality initiatives, audits, corrective actions, documentation, training, and continuous improvement.

The ideal candidate combines a strong scientific foundation with hands-on laboratory quality assurance experience and working knowledge of standards such as ISO/IEC 17025, GLP, and/or NELAC/TNI.

Key Responsibilities

• Lead and continuously improve the laboratory's Quality Management System (QMS).
• Maintain quality documentation, controlled records, SOPs, training records, and related quality systems.
• Coordinate and conduct internal audits to ensure compliance with applicable standards, accreditation requirements, laboratory procedures, and regulatory expectations.
• Support and coordinate external regulatory and accreditation audits.
• Identify nonconformances and oversee corrective and preventive actions (CAPA), root-cause investigation, follow-up, and continuous improvement initiatives.
• Manage proficiency testing schedules, reporting, documentation, and follow-up activities.
• Coordinate supplier qualification and traceability requirements.
• Maintain and archive GLP study-specific quality records.
• Review new method validations and method improvements for compliance with internal policies and regulatory requirements.
• Perform procedural audits of laboratory methods against approved SOPs and applicable regulatory requirements.
• Develop, review, and maintain Quality Management System SOPs and other controlled laboratory documentation.
• Prepare regulatory and client-facing reports, including analytical summaries, audit responses, and regulatory data packages.
• Report quality performance, audit findings, observations, nonconformances, and recommended corrective actions to laboratory leadership.
• Coordinate annual Quality Review Meetings and prepare the annual Management Review of the Quality System.
• Oversee verification and maintenance of scheduled calibration for laboratory support equipment.
• Conduct quality assurance and regulatory training for laboratory personnel.
• Communicate regulatory updates, quality concerns, operational changes, and improvement initiatives across laboratory teams.
• Provide QA-related support for client inquiries when needed.
• Supervise QA support personnel, including training, work assignments, performance management, and development.