Quality Manager

Quality Assurance Manager - LaboratoryLocation: Oregon Employment Type: Full-Time Department: Quality Assurance Industry: Laboratory Testing / Analytical SciencesPosition OverviewWe are seeking an experienced Quality Assurance Manager to lead and maintain the Quality Management System for an established analytical laboratory in , 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 , GLP, and/or NELAC/'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. 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 (RQAP) designation.-RQAP-GLP 're Looking ForWe'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 , technically credible, comfortable working directly with laboratory personnel, and capable of balancing regulatory requirements with practical laboratory , compliance, and continuous improvement.