Quality Control Pro - Data Integrity & Compliance

Regulatory Jobs; Portland (OR); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Health and wellbeing programmes

Retirement and pension plans

Learning and development opportunities

Inclusion and accessibility

Job summary

ICON is seeking a Quality Control Specialist in Portland, Oregon. The role focuses on QC reviews of study data and laboratory documentation to ensure accuracy, integrity, and regulatory compliance within a regulated environment.

You will support quality systems, document control, and continuous improvement, collaborating cross-functionally to maintain audit-ready records and timely quality deliverables.

Qualifications

• Minimum of five years of laboratory experience in a regulated environment.
• Working knowledge of GxP regulations and applicable industry guidance documents.
• Proficiency with Microsoft Office Suite applications.
• Experience utilizing laboratory instrument data systems.
• Strong attention to detail and commitment to data integrity.
• Excellent organizational, communication, and problem-solving skills.
• Ability to work independently while collaborating effectively across multiple departments.

Responsibilities

• Perform QC review of study participant results and laboratory run packets to ensure accuracy, completeness, and regulatory compliance.
• Review Biomarker Reports and supporting study documentation for data accuracy and integrity.
• Perform QC review of validation documentation and associated records.
• Review methods, reports, and supporting documentation for accuracy and proper formatting.
• Identify data discrepancies and communicate quality issues promptly.
• Support investigations and CAPA activities as needed.
• Provide backup for Incoming Materials review and QC of Production Batch Records.
• Read and comply with SOPs, safety requirements, and regulatory guidelines.

Skills

Attention to detail

Data integrity

Communication

Independent work

Cross-functional collaboration

Tools

Microsoft Office

LIMS

JMP

Job description

ICON is seeking a Quality Control Specialist in Portland, Oregon. The role focuses on QC reviews of study data and laboratory documentation to ensure accuracy, integrity, and regulatory compliance within a regulated environment.

You will support quality systems, document control, and continuous improvement, collaborating cross-functionally to maintain audit-ready records and timely quality deliverables.