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I
ICON
Quality Control Specialist - (Portland, Oregon OR)
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What they do
A Quality Control Analyst, in the biotech and medical device industries, works in laboratories performing biological, microbiological, and chemical tests on products and materials. Responsible for calibrating equipment, inspecting products, processing and testing materials, and reporting results. May work in other production environments to monitor and improve quality and efficiency in production systems and products.
$65,487 / year median in Oregon
-13% projected decline
Job Description
Quality Control Specialist - Portland, Oregon (OR) ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. Quality Control Specialist Position Summary The Quality Control Specialist is responsible for reviewing and maintaining laboratory data, documentation, and quality records to ensure accuracy, compliance, and adherence to established procedures and regulatory requirements. This role supports quality systems, data integrity initiatives, laboratory metrics reporting, and continuous process improvement efforts while serving as a key resource for quality review activities across the laboratory. Key Responsibilities Data Review & Compliance Review study participant results, laboratory run packets, biomarker reports, validations, and batch records to ensure accuracy, completeness, and compliance with applicable SOPs, protocols, and regulatory requirements. Evaluate methods, reports, and supporting documentation for consistency, quality, and adherence to established standards. Identify, document, and communicate data discrepancies, errors, and quality concerns in a timely manner. Assist with investigations and resolution of data and documentation issues to support overall study integrity and quality objectives. Read, understand, and comply with SOPs, safety requirements, regulatory guidelines, and company policies. Documentation & Records Management Maintain accurate, complete, and audit-ready records in accordance with regulatory, client, and company requirements. Support document control processes, including the creation, review, revision, and maintenance of controlled documentation. Compile and maintain laboratory notebooks, records, and departmental documentation for archival and compliance purposes. Ensure documentation practices remain consistent, organized, and inspection ready . Quality Systems & Continuous Improvement Compile, analyze, and report laboratory quality metrics to monitor performance and identify trends. Develop and maintain tracking tools related to deviations, errors, and quality indicators. Identify opportunities for process improvements based on data analysis, trend monitoring, and quality observations. Support initiatives focused on enhancing document control, quality systems, and operational efficiency. Provide backup support for incoming materials review and other quality-related activities as needed. Cross-Functional Support Collaborate with laboratory, operations, and quality teams to ensure timely completion of quality review activities. Support departmental projects and initiatives aimed at improving compliance, consistency, and overall laboratory performance. Adhere to all safety procedures and maintain a safe working environment. Qualifications Required Bachelor's degree in biology, Chemistry, Life Sciences, or a related scientific discipline; or equivalent combination of education and experience. Strong attention to detail and ability to review complex data and documentation for accuracy and completeness. Excellent organizational, analytical, and problem-solving skills. Effective written and verbal communication skills. Proficiency with Microsoft Office applications, including Excel, Word, and Outlook. Preferred Experience working in a regulated laboratory, quality assurance, quality control, pharmaceutical, biotechnology, or clinical research environment. Knowledge of Good Documentation Practices (GDP), SOPs, and applicable regulatory requirements. Experience with document control systems and quality management processes. Experience using JMP statistical software for data analysis, reporting, data visualization, and quality metric trending. Physical Requirements Ability to remain stationery and work at a computer for extended periods. Ability to occasionally lift and move materials up to company-defined limits. Ability to work in a laboratory and office environment as required.