Lab Technical Spec

Job Responsibilities

Oversees the technical aspects of disciplines within the clinical laboratories.

Establishes and monitors the standards of accuracy and precision in the performance of assays and/or the operation of equipment.

Aids in the development, revision, maintenance and yearly documented review of technical policy manuals.

Affirms that policy and procedures are written in Clinical and Laboratory Standards Institute (CLSI) or other designated format, and complies with Federal Standards.

Creates and carries out project plans meeting the needs of the laboratory section, vendor partner, regulatory agencies and other key stakeholders when implementing new sections or technologies in the laboratory.

Responsible for new test evaluation and introduction to include instrument validation, test validation, staff training, and establishing QC and writing final SOP.

Acts as the technical expert for instrument platforms to include method improvement, troubleshooting instruments, assays, interfaces and working with instrument vendor/specialist.

Collaborates with clinical trials and research as appropriate.

Problem Resolution

Researches and takes the lead in the resolution of problems.

Aids employees and managers in the interpretation of policies and procedures.

Aids managers and employees in understanding procedures and requirements for assigned department/division.

Takes the lead as a source of information regarding departmental/divisional issues.

Training Development/Delivery

Coordinates the training, education, and/or development of staff, new employees, patients, visitors, students, fellows, residents, and/or the community.

Develops in-service and other training curricula for labs related to specific discipline or research findings.

Educates staff for transition of new testing and/or LIS functions as necessary.

Process Improvement II

Identifies, leads, and directs process/quality improvement/assurance activities.

Measures and presents results of improvement efforts and ongoing performance measures of processes.

In collaboration with appropriate individuals, develops strategic plans for improvement.

May manage activities such as training and audits which support process improvement initiatives/activities.

May participate on process improvement team(s).

Data Management III

Develops/designs/create, evaluates, restructures, and/or manages specific database(s), including data related to research, trials and patient testing.

Inputs and ensures the integrity of data and/or records.

Standardizes and documents processes.

May coordinate data collection.

May conduct data analysis, create reports, and disseminate to the appropriate individuals.