Lab QA Specialist

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

Company Description

iCura Diagnostics, Inc. is a specialized Contract Research Organization (CRO) and a CLIA High Complexity‑certified, CAP‑accredited clinical diagnostic laboratory focused on spatial biology and translational research. The team provides advanced services in spatial phenotyping, tumor microenvironment mapping, multiplex immunofluorescence (mIF), IHC, histology, digital pathology, dPCR, qPCR, and next‑generation sequencing (NGS). Using cutting‑edge equipment, iCura delivers high‑resolution imaging and comprehensive tissue analysis to support scientific teams across the drug development pipeline. The organization helps partners identify predictive biomarkers, stratify patients, and uncover novel therapeutic targets. iCura offers end‑to‑end support including method development and validation, sample testing, regulatory compliance, and clinical trial logistics.

Role Description

The Lab QA Specialist is a full‑time, on‑site role based in Malvern, PA. This role is responsible for supporting and enhancing the laboratory quality management system to ensure compliance with internal standards, CLIA, CAP, and other applicable regulations. Day‑to‑day responsibilities include reviewing and approving assay validations, SOPs, and quality documentation, monitoring quality metrics, managing deviations, nonconformances, and change controls, and coordinating corrective and preventive actions (CAPA). The Lab QA Specialist will perform internal audits, support external inspections, oversee document control and training records, and help maintain equipment qualification and calibration documentation. This role collaborates closely with laboratory, operations, and regulatory teams to drive continuous quality improvement and ensure reliable, accurate diagnostic and research results.

Qualifications

• Demonstrated skills in Quality Control, including data review, trend analysis, and oversight of routine QC activities.
• Experience in Quality Assurance and Quality Management, with the ability to maintain and improve a laboratory quality management system.
• Working knowledge of Good Manufacturing Practice (GMP) or similar quality frameworks relevant to clinical or research laboratories.
• Background in Quality Auditing, including participation in or execution of internal audits and support of external inspections.
• Bachelor’s degree in a life science (e.g., Biology, Biochemistry, Molecular Biology) or a related field; advanced degree is a plus.
• Experience in a clinical, diagnostic, or research laboratory environment; familiarity with CLIA and CAP requirements preferred.
• Strong attention to detail, documentation accuracy, and organizational skills in a fast‑paced, highly technical setting.
• Ability to work collaboratively with cross‑functional teams and communicate clearly in both written and verbal formats.
• Comfort with electronic quality systems, LIMS, or other digital tools used for document control and quality tracking.