LIMS Configuration Manager
The LIMS Configuration Manager supports the Diagnostic Laboratory’s computer systems and lab instruments/equipment. Works with Lab Management and personnel to define user requirements and specifications for Lab Operations, Clinical, Manufacturing and Quality Control. Provide system administration and manages configuration for all computer-based laboratory systems, including the LIMS and perform activities required for configuration, validation, troubleshooting and user training for computer-based laboratory systems.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Responsible for the configuration and management of the LIMS and other operational software in the lab that drive lab processes, supports the instruments or devices, manages documents, or measures performance in accordance with SOPs.
- This includes periodic audit of users and roles in LIMS and other systems used in the lab, configuration of the LIMS for implementing configuration changes to Dx test methods and assays as well as configuration necessary for execution of assays (such as LES, standards, controls, reference ranges).
- Configuration and management of the LIMS may extend to other departments using the LIMS such as Manufacturing, Process Development, Clinical Operations, Client Operations, and Research.
- Works with Lab Personnel to define LBRs for various assays and their configuration in the LIMS.
- Works with Tech Operations and Information Services (IS) to ensure effective integration of laboratory instruments and devices to the LIMS.
- Works with Metrology, Tech Ops, and IS to ensure the proper maintenance and management of lab instruments in the Lab.
- Provides “ad hoc” reporting or analysis on behalf of the Dx Lab.
- Partners with IS, Research, Product Development, Technical Ops, Manufacturing & QC for transfer of new assays to Operations or to modify existing lab tests. This includes management of changes to Dx product specifications such as Laboratory Test Specifications (LTS), Laboratory Assay Method Specifications (LAMS).
- Support lab management in the assessment of business and regulatory risk and impact of computer-based laboratory systems and related processes.
- Recommend standards for computer-based lab equipment and ensure appropriate processes/procedures to meet applicable compliance requirements.
- Works with IS to plan and manage changes to laboratory systems.
- Assess data management and records organization needs related to computer-based laboratory equipment. Manage lab software media and licensing in conjunction with IS.
- Participates in Lean Six Sigma activities and implement solutions for removing waste and reducing variations in the CLIA laboratory.
- May participate in organizational project teams and serve as a technical expert to internal departments.
- Comply with company policies and regulations.
EDUCATION and/or EXPERIENCE
This position generally requires a Bachelor’s degree from four-year college or university and 8-10 years of related experience and/or training; or equivalent combination of education and experience. Requires experience configuring and managing a commercial LIMS. Experience working with LabVantage LIMS is a strongly preferred. Requires experience in LIMS/medical instrumentation data transfer interfaces and a background in Medical Technology or Biotechnology. Must possess strong interpersonal, written and oral communication skills and the ability to develop good working relationships. Preferred: 2-3 years of experience in methodologies and instrumentation of Immunochemistry assay determinations, High Pressure Liquid Chromatography, Flowcytometry, and/or DNA SNP determinations. Preferred experience or background in Parametric and Nonparametric univariant and multivariant statistics. Experience working in GLP/GMP/FDA/CLIA regulated environment, especially under the Design Control System, strongly preferred. Experience working as a liaison with multiple departments, including IS/IT. Experience developing formal requirements and specifications.
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Ability to work with mathematical concepts such as probability and statistical inference, and fundamental of plane and solid geometry and trigonometry.
Ability to define problems, collect data, establish facts and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
All qualified applicants are considered regardless of race, religion, color, age, sex, sexual orientation, gender identity, marital status, nationality, veteran status or disability.