Laboratory QA Manager - QMS & Compliance Leader

Smartsearchonline; Portland (OR); On-site; USD 90,000 - 125,000; Full time

Job summary

Smartsearchonline in Oregon seeks an experienced Quality Assurance Manager to lead the Quality Management System for a laboratory. You will ensure regulatory compliance, maintain documentation, and drive continuous improvement across the QA program.

The role requires a Bachelor’s degree in Chemistry or a related field and at least 2 years of QA experience in a regulated lab, with familiarity in ISO/IEC 17025, GLP, and NELAC/TNI. Collaboration with leadership and staff is essential to success.

Qualifications

• Bachelor's degree in Chemistry or related scientific discipline.
• Minimum 2 years of QA experience in a regulated laboratory.
• Knowledge of QMS and regulatory compliance.
• Experience with ISO/IEC 17025, GLP, NELAC/TNI, or comparable standards.
• Experience conducting or supporting quality system audits.
• Experience managing CAPA and continuous improvement processes.
• Strong technical writing skills with SOP development and documentation.
• Ability to interpret regulations and accreditation requirements.
• Proficiency with Microsoft Office.

Responsibilities

• Lead and continuously improve the laboratory's Quality Management System (QMS).
• Maintain quality documentation, SOPs, and training records.
• Coordinate and conduct internal audits for compliance with standards.
• Support external regulatory and accreditation audits.
• Oversee CAPA, root-cause analysis, and corrective actions.
• Manage proficiency testing schedules and reporting.
• Coordinate supplier qualification and traceability requirements.
• Review method validations for regulatory compliance.
• Audit laboratory methods against SOPs and regs.
• Develop and maintain QMS SOPs and controlled documents.
• Prepare regulatory and client-facing reports and data packages.
• Report quality performance to laboratory leadership.
• Coordinate annual Quality Review Meetings and Management Review.
• Oversee calibration verification for support equipment.
• Provide QA training to laboratory personnel.
• Communicate regulatory updates and quality initiatives across teams.
• Offer QA support for client inquiries as needed.
• Supervise QA staff, including training and performance management.

Skills

Quality Assurance

Regulatory Compliance

Auditing

CAPA

Technical Writing

SOP Development

Problem Solving

Analytical Thinking

Cross-functional Collaboration

Training

Education

Bachelor's degree in Chemistry or related scientific discipline

Tools

Microsoft Office

Job description

Smartsearchonline in Oregon seeks an experienced Quality Assurance Manager to lead the Quality Management System for a laboratory. You will ensure regulatory compliance, maintain documentation, and drive continuous improvement across the QA program.

The role requires a Bachelor’s degree in Chemistry or a related field and at least 2 years of QA experience in a regulated lab, with familiarity in ISO/IEC 17025, GLP, and NELAC/TNI. Collaboration with leadership and staff is essential to success.