Quality Control Specialist - (Portland, Oregon OR)

Quality Control Specialist - Portland, Oregon (OR)

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

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.

What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply