Quality 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

Job Details

Quality Manager Portland,OR Posted:8/10/2026 Job Description Job ID#: 86817

Job Category: Administration

Position Type: Direct

Duration: Direct Hire

Shift: 1

Quality Assurance Manager - Laboratory

Location: Oregon

Employment Type: Full-Time

Department: Quality Assurance

Industry: Laboratory Testing / Analytical Sciences

Position Overview

We are seeking an experiencedQuality 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 asISO/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.

Job Requirements

Required Qualifications

• Bachelor\'s degree in Chemistry or a related scientific discipline.
• Minimum 2 years of Quality Assurance experience in a regulated laboratory environment, or an equivalent combination of education and relevant experience.
• Knowledge of laboratory Quality Management Systems and regulatory compliance.
• Experience with ISO/IEC 17025, GLP, NELAC/TNI, or comparable laboratory accreditation/regulatory standards.
• Experience conducting or supporting quality system and procedural audits.
• Experience managing or participating in CAPA and continuous improvement processes.
• Strong technical writing skills with experience developing or maintaining SOPs, quality documentation, reports, and procedures.
• Ability to interpret technical procedures, laboratory methods, governmental regulations, and accreditation requirements.
• Strong analytical, investigative, and problem-solving capabilities.
• Proficiency with Microsoft Office.

Preferred Qualifications

• Previous hands-on analytical laboratory experience.
• Experience supporting regulatory or accreditation inspections and external audits.
• Experience with laboratory method validation and verification.
• Experience managing proficiency testing programs.
• Experience supervising or leading QA personnel.
• Experience working across multiple laboratory or business departments.
• Experience implementing process or quality-system changes.
• Familiarity with FDA and/or state regulatory reporting requirements.
• Experience working within an international or globally connected organization.
• Registered Quality Assurance Professional (RQAP) designation.
• RQAP-GLP certification.

What We're Looking For

We\'re looking for someone who sees Quality Assurance as more than maintaining documentation. This individual should be comfortable identifying gaps, challenging existing processes when necessary, and partnering with laboratory leadership to strengthen quality and regulatory compliance. The right candidate will be highly organized, technically credible, comfortable working directly with laboratory personnel, and capable of balancing regulatory requirements with practical laboratory operations. This is an excellent opportunity for an experienced laboratory QA professional who wants ownership of a Quality Management System and the ability to make a measurable impact on laboratory quality, compliance, and continuous improvement.

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