Lab QA Specialist — CLIA/CAP Diagnostics Quality Lead

iCura Diagnostics, Inc; Malvern (Chester County); On-site; USD 60,000 - 80,000; Full time

Job summary

iCura Diagnostics, Inc in Malvern, PA is looking for a Lab QA Specialist to enhance their laboratory quality management system. This full-time, on-site role involves ensuring compliance with internal standards and applicable regulations, managing quality metrics, and coordinating corrective actions.

The ideal candidate will demonstrate skills in Quality Control and Assurance, possess a Bachelor’s degree in a life science, and have experience in a clinical or research laboratory environment. Strong attention to detail and collaboration skills are vital.

Qualifications

• Demonstrated skills in Quality Control, including data review and trend analysis.
• Experience in maintaining and improving laboratory quality management system.
• Background in Quality Auditing with experience in internal audits.

Responsibilities

• Support laboratory quality management system to ensure compliance.
• Review and approve assay validations, SOPs, and quality documentation.
• Perform internal audits and support external inspections.

Skills

Quality Control

Quality Assurance

Good Manufacturing Practice (GMP)

Quality Auditing

Documentation Accuracy

Collaboration

Electronic Quality Systems

Education

Bachelor’s degree in a life science

Job description

iCura Diagnostics, Inc in Malvern, PA is looking for a Lab QA Specialist to enhance their laboratory quality management system. This full-time, on-site role involves ensuring compliance with internal standards and applicable regulations, managing quality metrics, and coordinating corrective actions.

The ideal candidate will demonstrate skills in Quality Control and Assurance, possess a Bachelor’s degree in a life science, and have experience in a clinical or research laboratory environment. Strong attention to detail and collaboration skills are vital.