Quality Assurance Associate

Quality Assurance Associate
Industry: Analytical Laboratory | Life Sciences | Food Safety | Environmental Testing
Location: Portland, Oregon area
Employment Type: Full Time
Compensation: $49,000 ? $75,000 annually

Overview

A regulated analytical laboratory within the life sciences and food safety testing industry is seeking a Quality Assurance Associate to support quality systems, regulatory compliance, and laboratory audit activities. This role works closely with the Quality Assurance Manager to maintain the laboratory's Quality Management System, support ISO 17025 compliance, and ensure quality standards are upheld across laboratory operations.

The ideal candidate has experience working in a regulated laboratory environment and understands laboratory documentation, audits, and regulatory quality systems.

Key Responsibilities

* Support maintenance and continuous improvement of the laboratory Quality Management System (QMS)
* Assist with internal audits to ensure compliance with ISO 17025 and other applicable regulatory standards
* Conduct procedural audits of laboratory methods to verify adherence to SOPs and quality standards
* Review laboratory documentation including training records, instrument logs, and analytical records for compliance
* Assist with corrective and preventative action programs and quality improvement initiatives
* Maintain document control systems to ensure laboratory documentation remains accurate and current
* Support proficiency testing programs including scheduling, reporting, and follow up activities
* Maintain supplier qualification records and traceability within the laboratory systems
* Assist with external regulatory audits and implementation of corrective actions when needed
* Support quality assurance training and communicate quality initiatives with laboratory personnel
* Maintain quality system records including audit reports, training records, and controlled documentation
* Assist with tracking and maintaining laboratory equipment calibration, verification, and maintenance records
* Coordinate calibration and repair of laboratory equipment with external vendors when required
* Support proper tracking of laboratory reagents, reference materials, and solutions to ensure traceability and compliance
* Maintain laboratory records within LIMS systems to support quality tracking and equipment identification
* Assist with quality documentation reviews prior to inclusion in document control systems
* Support record retention and archival processes to ensure regulatory and contractual compliance

Qualifications

* Bachelor's degree in Chemistry, Biology, Environmental Science, or a related scientific discipline
* 2+ years of experience in a Quality Assurance or regulated laboratory environment
* Experience working with laboratory quality standards such as ISO 17025, GLP, or similar regulatory frameworks
* Experience supporting laboratory internal audits and documentation review
* Familiarity with laboratory equipment, testing methods, and analytical processes
* Strong technical writing skills and experience working with SOPs and controlled documentation
* Strong analytical, organizational, and problem solving skills
* Ability to manage multiple priorities and meet deadlines in a regulated environment
* Proficiency with Microsoft Office and laboratory documentation systems

Preferred Qualifications

* Experience working in food safety testing, analytical chemistry, environmental testing, or life sciences laboratories
* Experience working with LIMS systems
* Experience supporting equipment calibration programs and laboratory compliance documentation

Work Environment

* Laboratory based work environment utilizing analytical testing equipment
* Exposure to laboratory chemicals and solvents within controlled safety protocols