Lab Technical Spec

Cincinnati Children's

14h•$74,298 - $94,744•Onsite

About The Position

The Lab Technical Spec oversees the technical aspects of disciplines within the clinical laboratories. This role establishes and monitors the standards of accuracy and precision in the performance of assays and/or the operation of equipment. The position assists in the development, revision, maintenance, and yearly documented review of technical policy manuals, ensuring compliance with CLSI or other designated formats and Federal Standards. The Lab Technical Spec creates and carries out project plans for implementing new sections or technologies, meeting the needs of the laboratory section, vendor partners, regulatory agencies, and other key stakeholders. This role is responsible for new test evaluation and introduction, including instrument validation, test validation, staff training, and establishing QC and writing final SOPs. The Lab Technical Spec acts as the technical expert for instrument platforms, focusing on method improvement, troubleshooting instruments, assays, and interfaces, and collaborating with instrument vendors/specialists. Additionally, the role coordinates clinical trials and research as appropriate.

Requirements

Bachelor of Science Degree in Clinical Laboratory Science OR or equivalent combination of education and experience
4+ years of high-complexity clinical laboratory experience

Nice To Haves

Management/leadership experience
Certified by national certifying agency

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.
Assists in the development, revision, maintenance and yearly documented review of technical policy manuals.
Assures 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.
Coordinates clinical trials and research as appropriate.
Research and take the lead in the resolution of problems.
Assist employees and managers in the interpretation of policies and procedures.
Assist managers and employees in understanding procedures and requirements for assigned department/division.
Take the lead as a source of information regarding departmental/divisional issues.
Coordinate 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.
Identify, lead, and direct process/quality improvement/assurance activities.
Measure and present results of improvement efforts and ongoing performance measures of processes.
In collaboration with appropriate individuals, develop 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).
Develop/design/create, evaluate, restructure, and/or manage specific database(s), including data related to research, trials and patient testing.
Input and ensure the integrity of data and/or records.
Standardize and document processes.
May coordinate data collection.
May conduct data analysis, create reports, and disseminate to the appropriate individuals.