• Ensures regulatory preparedness at all times by maintaining procedure manuals, training records, validation documents, personnel records, quality documentation, etc. while adhering to CAP, CLIA, and OSHA standards;
• Maintain procedural manuals in applicable areas of the laboratory;
• Participates in laboratory audits and accreditation inspections, at the capacity requested by QA management;
• Acts as a liaison between all departments in the laboratory (including Pre-Analytic, Analytic, and Post-Analytic) and the QA department to answer quality-related questions, implement policies/procedures, and enforce quality objectives;
• Ensures the Document Control System maintains the integrity and organizational standards set by QA management.
• Executes minor changes to controlled documents (as requested) in the Document Control System;
• Ensures that all equipment, machines, or instruments are maintained, inspected, and calibrated;
• Keeps records of applicable service and maintenance agreements as well as logs, as applicable;
• Executes verification of laboratory documentation (e.g., temperature/humidity monitoring, various logs, etc.) on a routine basis established by the QA department;
• Maintains knowledge of proper specimen collection procedures, including patient preparation, labeling, handling, preservation, processing, preparation, transportation, and storage of specimens;
• Obtains QA documentation and data to assist in the creation of monthly/annual Quality Reports, as well as establish effective systems to monitor accuracy assessments and data quality throughout the laboratory;
• Manages laboratory staff contact information
• Conducts QA procedures to monitor core performance and notifies QA management and area supervisor of performance issues as the issues develop, and work with the area supervisor to establish a remediation plan;
• Provides orientation/training to all new hires as well as current staff, as needed;
• Participates on subspecialty committees, corporate committees, and regional committees as needed;
• Accepts responsibilities delegated from the QA Supervisor or Director (the QA Supervisor or Director is permitted to delegate responsibilities to the QA Analyst, if the QA Analyst is qualified to perform the responsibility);
• Maintains licensures as applicable and participates in continuing education; ensure staffing does the same;
• Performs other duties as assigned;
• Acts as a member of the Safety and QA/PI Committee, attend meetings and implement changes, as needed:

• Participates as a member of other committees, as assigned;
• Pulls monthly QA data and follow through on issues report in a timely manner;
• Reviews and maintains records of maintenance;
• Participates with the QA department in overseeing the all clinical laboratory departments in a manner conducive to optimal performance and high morale;
• Follows the laboratory’s procedures for specimen handling and processing, test analyses, reporting, and maintaining records of patient test results; and
• Maintains records that demonstrate that proficiency testing samples are tested in the same manner as patient specimens.

COLLABORATIVE DUTIES:

• None

• To perform this job successfully, an individual must be able to perform each essential duty competently.
• The requirements listed below are representative of the knowledge, skill, and/or ability required. A minimum of an associate degree or high school Diploma with 2 years of clinical lab experience.

• None.

• High ability to communicate in English, written and verbally, with all levels of the organization
• Ability to create and present presentations to small and large groups

• Basic math skills; Ability to create and work with statistical data

• Moderate to advanced skill level in Microsoft Office Products (Excel, Word, PowerPoint, etc.) and Adobe Acrobat;
• Ability to perform, create, and interpret statistical data for validations, correlations, etc.; and
• Ability to quickly learn proprietary software programs (e.g. LIS, MediaLab, Asana, etc.).