Description
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 Quality Control Specialist, you will play a critical role in ensuring the accuracy, integrity, and compliance of laboratory data, documentation, and quality records.
Position Overview
The Quality Control Specialist performs quality control reviews of study-related data and laboratory documentation, supports quality systems and document control processes, monitors laboratory quality metrics, and contributes to continuous improvement initiatives.
Key Responsibilities
- Data Review & Compliance:
+ Perform quality control reviews of study participant results and laboratory run packets + Conduct reviews of Biomarker Reports and supporting study documentation + Perform QC reviews of validation documentation and associated records + Review methods, reports, study data, and supporting documentation for accuracy and consistency
- Documentation & Records Management:
+ Maintain accurate and complete records + Support document control activities + Develop and support improvements to document control processes
- Quality Systems & Continuous Improvement:
+ Compile, maintain, analyze, and report laboratory quality metrics + Develop and maintain tracking tools related to quality events and deviations + Identify opportunities for process improvement
- Cross-Functional Support:
+ Collaborate with laboratory, operations, project management, and quality teams + Support departmental projects and initiatives
Qualifications & Experience
- Required 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
- Preferred Qualifications:
+ Experience using JMP statistical software + Experience supporting sponsor audits and regulatory inspections + Knowledge of laboratory quality systems and document control processes
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.