Job Details

Position Summary:

The Lab IT Quality Assurance (QA) Supervisor is responsible for overseeing the quality assurance and regulatory compliance of all laboratory information technology systems. This includes the validation, verification, documentation, and change control processes related to Laboratory Information Systems (LIS), middleware, instrument interfaces, and other laboratory software solutions. The supervisor ensures that all IT systems used in the laboratory environment meet regulatory, accreditation, and internal quality standards.

Key Responsibilities:

• Supervise the development and execution of validation protocols (IQ/OQ/PQ) for LIS, laboratory IT systems, and third part downstream systems.
• Manage QA processes related to lab IT systems, including system upgrades, patches, change control, and user access controls.
• Ensure compliance with applicable regulatory and accreditation standards (e.g., CLIA, CAP, FDA, HIPAA, AABB, COLA) for all laboratory IT systems.
• Collaborate with lab management, IT, and vendors to assess system performance, troubleshoot issues, and implement improvements.
• Lead and conduct audits, risk assessments, and gap analyses for lab IT systems.
• Maintain SOPs and documentation related to lab IT QA processes, system validation, and regulatory compliance.
• Participate in project planning for the implementation or modification of lab systems, ensuring QA practices are integrated throughout.
• Monitor system data integrity, incident tracking, and deviation management.
• Stay up to date on evolving regulatory requirements and best practices in lab IT and quality assurance.

Required Qualifications:

• Medical Laboratory Science or Medical Laboratory Technologist Degree/Certification
• Minimum of 3 years of experience in a clinical laboratory
• Experience with LIS systems (e.g., Epic Beaker, Sunquest, Cerner) and lab instrumentation interfaces.
• Strong understanding of QA principles, software/system validation, and regulatory standards (e.g., CLIA, CAP, FDA).
• Excellent documentation, analytical, and organizational skills.
• Strong interpersonal and communication skills with the ability to lead and collaborate across teams.

Preferred Qualifications:

• ASCP certification (e.g., MLS(ASCP)) or equivalent.
• Experience with HL7 messaging, database queries, and middleware configuration.
• Prior supervisory or leadership experience.

Working Conditions:

• Office and laboratory environment; occasional exposure to laboratory reagents or biological materials.
• Use of personal mobile phone and reliable home internet are required.
• Analyst positions in IT are fixed salary; work may be required outside normal, daytime business hours (i.e., on-call support, system implementations, emergency outages, etc.).
  • Agreement to COA IT Remote Work Procedure required.
  • Hybrid work schedule