Description

Job Summary

The Customer Tools Specialist supports development of tools that simplify for customers the process of onboarding new bioMerieux molecular IVD tests and demonstrating routine regulatory compliance. These tools include Verification and Proficiency testing materials and associated protocols and customer-facing literature. This position is primarily responsible for hands-on testing of materials, data analysis, data presentation, and reporting of results. The position has some collaboration with outside manufacturers regarding the technical development and monitoring of external QC, Verification, and Proficiency Testing materials used by bioMerieux customers as well as drafting literature and monitoring issues with those materials; this may include testing of materials and recording of data in accordance with established protocols and work instruction documents, regulations, safety requirements, and the quality system. Knowledge/experience regarding US regulatory guidelines associated with the use molecular diagnostics is desired. Familiar with a variety of the field's concepts practices, and procedures including nucleic acid preparation, PCR, RT-PCR, real-time PCR, and use of fluorescence-based nucleic acid detection techniques. May supervise the work of others.

Essential Job Duties and Responsibilities

1. Performs all work for assigned projects/experiments in compliance with company policies and within the guidelines of the company's Quality System.
2. Uses professional concepts to contribute to the development of company processes and principles and to achieve objectives in creates and effective ways.
3. Performs work related to development, validation, and life cycle maintenance and support of Verification and Proficiency testing materials and protocols for bioMerieux molecular in vitro diagnostic tests.
4. Primary responsibility involves hands-on testing of samples with relevant bioMerieux products, analyzing resulting data, and presenting results to appropriate stakeholders.
5. Assists in generating and maintaining technical documents related to the use of verifications, external quality controls, and QC risk analysis.
6. Participates in proficiency sample testing program(s) and report results to relevant internal stakeholders.
7. May interact with external regulatory bodies as needed.
8. May work with Technical Support and Postmarket Surveillance regarding customer issues with the use of verification and quality control materials.
9. Coordinates with bioMerieux support regarding Customer Tools needs outside the US.
10. Coordinates with Investigation Coordinator regarding non-conformance relevant to Customer Tools and communicates work that needs to be done for resource assignment.
11. May write internal studies and design documents as necessary.

12. Maintains a broad knowledge of state-of-the-art principals and theories.
13. May attends and presents at scientific conferences.
14. Interacts with various company departments, including Sales, Marketing, Development, Legal, Management, Regulatory, Postmarket Surveillance, Production, Tech Support, and Quality personnel.
15. Demonstrates potential for technical proficiency, collaboration with others, and independent thought.

Supplemental Data

* Performs work independently.
* Works full time onsite.

Training and Education

* Bachelor's or Master's degree in a scientific discipline.

Experience

* A minimum of 5 years' experience in an academic, industry, or healthcare laboratory.

Knowledge, Skills, and Abilities

* Has working knowledge of current and evolving microbiology and molecular biology principles, tools, and techniques relevant to developing diagnostic tests for infectious diseases.
* Comfortable working in a dynamic environment where priorities sometimes change on short notice.
* Excellent verbal and written communication skills, scientific creativity, strong interpersonal skills, and independent thought.
* Demonstrated history of planning, organizing, and executing collaborative projects, analyzing qualitative and quantitative data, and generating scientific training documentation.
* Strong organizational and project management skills.
* Ability to collaborate effectively, build productive relationships and to work with a variety of people.
* Computer literacy and proficiency are required.

* Advanced understanding of molecular diagnostics and their use in CLIA-mod/-waived regulatory settings.

Physical Requirements

* Must be able to lift and safely maneuver 40 lbs.