Quality Assurance Manager
Industry: Analytical Laboratory | Life Sciences | Environmental Testing
Location: Portland, Oregon area
Employment Type: Full Time
Overview
A growing analytical laboratory operating within the life sciences and environmental testing space is seeking a Quality Assurance Manager to lead quality systems, regulatory compliance, and laboratory audit programs. This role is responsible for maintaining the laboratory Quality Management System, supporting ISO and GLP compliance, and partnering with laboratory leadership to ensure high standards of analytical quality and regulatory adherence.
The ideal candidate has experience in regulated laboratory environments, strong knowledge of ISO 17025 or GLP standards, and a track record of managing audits, quality systems, and laboratory documentation.
Key Responsibilities
* Lead and maintain the laboratory Quality Management System (QMS) to ensure regulatory compliance and operational quality
* Oversee document control, quality records, training documentation, and traceability systems
* Manage internal and external audits, including preparation, execution, documentation, and corrective actions
* Ensure compliance with ISO 17025, GLP, NELAC, and other applicable laboratory regulatory standards
* Review and approve laboratory SOPs, method validations, and controlled documentation
* Conduct procedural audits to verify laboratory methods are performed according to approved SOPs and regulatory requirements
* Manage corrective and preventative action programs (CAPA) and continuous improvement initiatives
* Coordinate proficiency testing programs, reporting, and follow up actions
* Prepare regulatory and client reports including audit responses and analytical summaries
* Coordinate annual quality system reviews and management review meetings
* Ensure proper calibration and verification of laboratory equipment
* Deliver quality training to laboratory staff and communicate regulatory updates and quality improvements
* Partner with laboratory leadership to identify quality improvement opportunities and strengthen operational processes
Supervisory Responsibilities
* Supervise QA Associate or QA Assistant personnel
* Assist with interviewing, hiring recommendations, and onboarding
* Provide training, performance management, and workflow oversight
Qualifications
* Bachelor's degree in Chemistry, Biology, Environmental Science, or a related scientific discipline
* 2+ years of Quality Assurance experience in a regulated laboratory environment
* Experience supporting laboratory accreditation and regulatory compliance programs
* Strong knowledge of ISO 17025, GLP, NELAC, or similar laboratory quality standards
* Experience conducting internal audits and supporting external regulatory audits
* Strong technical writing skills with experience drafting SOPs and quality documentation
* Excellent analytical, problem solving, and communication skills
* Proficiency with Microsoft Office and laboratory quality documentation systems
Preferred Qualifications
* Registered Quality Assurance Professional (RQAP) or RQAP-GLP certification
* Experience working in environmental testing, analytical chemistry, or life sciences laboratories
* Experience managing CAPA programs and laboratory quality improvement initiatives
Work Environment
* Laboratory based work environment utilizing analytical testing equipment
* Exposure to laboratory chemicals and solvents within controlled safety protocols