POSITION SUMMARY
Position plans, coordinates, implements and evaluates quality/performance improvements activities, including validation testing. Coordinates validation, compliance and regulatory programs for preparedness and accreditation requirements in conjunction with Laboratory Sciences of Arizona/Sonora Quest Laboratories (LSA/SQL) and System Quality, Risk, Compliance departments. Responsible for designing, developing, and executing quality assurance and control processes, test plans and test cases that verify conformance to defined acceptance criteria. Provides management of quality assurance, risk management, and compliance activities through oversight, consultation, and resolution of problems arising within LSA/SQL IT.
ESSENTIAL FUNCTIONS
1. Tracks and manages the overall testing effort of a project, the IT Quality Assurance team, the Quality Assurance process and / or the execution of the test plan:
a.Ensures that the testing can be completed on time and meets all functional requirements, as defined during the requirement definition process.
b.Ensures products, applications and systems are in compliance with overall quality and compliance for the System as it relates to the Laboratory Information Systems (LIS) and Billing Information Systems (BIS) as defined by the appropriate LSA/SQL IT Director(s) and IT Technical Director(s).
2. Develops comprehensive use cases/testing plans and analyzes data for administrative, and clinical decision making, as well as regulatory requirements, within the IT department. Ensures necessary knowledge management documentation to ensure accuracy and completeness of the documentation.
3. Coordinates implementation of data collection processes: proved analysis, summary, research and benchmarking. Prepares and presents reports for appropriate facility, system, and other external agencies. Provides oversight to projects including data abstracting and data entry as appropriate.
4. Oversees and coordinates the investigation, analysis, and responses to Quality, Compliance, Risk issues, events, and trends within IT.Leads and/or facilitate root cause analysis as it relates to Quality, Compliance, and/or Risk events within the IT.
5. Oversees and coordinates the preparation of, and assists with, internal and external audits at a department, site, and system level for both commercial (SQL) and hospital (LSA) entities as it relates to the Laboratory Information Systems (LIS) and Billing Information Systems (BIS).Ensures compliance with accrediting, regulatory, and auditing agencies.
6. Oversees and coordinates the investigation of critical incidents within IT and prepares reports of findings and provides recommendations for corrective action implementation.Develops and maintains mechanisms to track, monitor, and implement improvement actions; and establishes a process which evaluates the success of those improvement actions.
MINIMUM QUALIFICATIONS
• Bachelor’s Degree in Clinical or Lab Sciences or related field.
• Five (5) years’ laboratory experience including four (4) years’ in high complexity laboratory testing.
• Three (3) years’ of management/supervisory experience.
• Analytical and conceptual thinking ability to balance and manage multiple projects simultaneously; good working knowledge of IT, risk management, quality assurance management, and compliance regulations as they relate to the laboratory industry.
• Excellent customer service, communication, and documentation skills.
• Ability to perform complex statistical analysis and highly developed problem solving skills.
• Current, proficient experience with Microsoft Access, Excel, OneNote, Outlook, PowerPoint, and Word.
PREFERRED QUALIFICATIONS
• General knowledge of information technology in a laboratory setting.
• Additional related education and/or experience.
• Six-Sigma Green Belt (or obtain certification within 2 years of hire).
