What are the responsibilities and job description for the Quality Control Specialist position at ClinLab Solutions Group?
On- site (Phoenix) opportunity for a Quality Control Specialist with GCP experience.
Key Responsibilities
- Conduct routine quality audits of study files, source documents, and regulatory binders
- Review CRFs and EDC entries for accuracy, completeness, and protocol compliance
- Monitor adherence to ICH-GCP guidelines, FDA regulations, and institutional SOPs
- Serve as liaison for sponsor monitoring visits, audits, and regulatory inspections
- Track and ensure timely resolution of audit findings, CAPAs, and data queries
- Oversee investigational product accountability and temperature monitoring logs
- Identify protocol deviations, document trends, and implement corrective actions
- Develop and maintain site SOPs, quality metrics, and training materials
- Support adverse event reporting and informed consent process quality checks