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Job Description
For over 40 years, DiaSorin has been on a mission on five continents to develop, produce and commercialize diagnostic tests for a wide range of clinical areas. Our tests are designed for hospitals and private testing laboratories, in the markets of immunodiagnostics and molecular diagnostics. We believe in a respectful and supportive workplace that attracts and celebrates the uniqueness of a diverse workforce that represents our community and customers.
Position Summary
Provide support to Field Applications department, Regional Manager and team with responsibilities and instruction. Provide mentoring, leadership and technical expertise and support to Field Applications department and all colleagues. Perform customer training and education on existing and new products and instrumentation. Provide instrumentation, biochemistry and assay application expertise to external and internal customers. Support customer assay and analyzer validation studies (per US laboratory regulatory guidelines and requirements). Provide customer support including technical troubleshooting of instrumentation, biochemistry, quality control, project management, workflow, PC applications and network interfacing of instrumentation to customer LIS systems.
Key Duties and Responsibilities
* Provide training and educational support to internal and external customers with regard to assay and instrument operation, instrument maintenance, instrument calibration, and troubleshooting.
* Assist customer with implementation of DiaSorin systems into their work environment. Activities may include correlation studies, correlation reports, assistance with LIS interface issues and questions, and recommendations for how to efficiently process the laboratories sample workload.
* Assist internal and external customers in product investigation/complaints, to ensure customer satisfaction, regulatory compliance, and problem resolution.
* Provide assistance to Sales and Marketing through training, defining customer requirements, determining instrument platform to meet the customer requirements, and customizing workflows.
* Provide operator training for internal and external customers on DiaSorin’s instrument platforms and assay product lines.
* Communicate results of customer visits to DiaSorin personnel involved with a particular account
* Provide support to Field Applications’ responsibilities.
* Participate in trade shows, webinars, educational opportunities, and other similar activities where Field Applications personnel involvement is required.
* Understand and utilize documentation protocols and accurately and legibly complete all documentation consistent with cGMP and other quality and regulatory requirements.
* Understand the appropriate Universal Operating Procedures (UOPs) pertaining to the work to be performed.
* Review, understand, and accurately complete in a timely fashion all documentation pertaining to the work to be performed, such as procedures, forms, and worksheets.
* Route, handle and/or store completed documentation appropriate for the work completed.
* Follow DiaSorin established compliance procedures designed to ensure that all regulatory requirements are met; activities may include audits, documentation, and the understanding of the requirements of agencies such as OSHA, EPA, NRC, and FDA.
* Apply understanding of NCCLS, CAP and CLIA requirements related to customer needs.
* Assist Management in gathering, monitoring and preparation of statistical information and other data utilized to support tracking, continuous improvement and objectives of the department.
* Perform work in a safe manner consistent with DiaSorin’s health, safety and environmental policies and assume responsibility for personal safety and that of co-workers to result in a safe work environment for all employees and the protection of the environment and the community at large.
* Follow DiaSorin’s established procedures for the safe handling and disposal of hazardous, radioactive and infectious material.
* Participate in DiaSorin’s safety training programs and demonstrate competency in the use of Material Safety Data Sheets, chemical labeling, corporate emergency response procedures, and DiaSorin’s Health, Safety, and Environmental policies.
Other Duties and Responsibilities
* Develop instrument applications on existing and new instruments as identified by Marketing
* Provide training and support infrastructure for new systems
* Develop training materials as required.
* Perform service instrumentation as needed
* Assist sales/marketing in providing assay and instrument demonstrations to customers
* Other duties may be assigned based on department or company business needs
Education, Experience, and Qualifications
* Bachelors degree in Life Sciences (i.e. Biology, Biochemistry, Chemistry), MLT/MT (ASCP, CLS or NCA) or equivalent; Masters and/or PhD preferred
* 3-5 years in a clinical lab setting or Medical Device/Diagnostics/Pharmaceutical industry
* 0-2 years as a Field Applications Specialist and/or equivalent industry experience
* Certifications Preferred: MT (ASCP), CLS or NA, Project Management, Lean Six Sigma, Quality Control, LIS/Interfacing
* Knowledge and skill in maintaining, validating, servicing, and troubleshooting analytical or medical diagnostic instrumentation
* Understanding of regulatory requirements relating to customer laboratory needs (i.e. CAP, CLIA, COLA)
* Understanding of good laboratory practices (GLPs)and techniques
* Basic understanding of laboratory information systems (LIS)
* Ability to:
* Demonstrate and explain correct operation and maintenance of equipment/instrumentation
* Do corrective action and troubleshooting with reference to manufacturers’ manuals
* Learn new software applications with minimal instruction
* Obtain address information, obtain travel itinerary, and travel to customer sites
* Work independently
* Read, analyze, and interpret general business periodicals, professional journals, technical procedures, and/or governmental regulations
* Write reports, business correspondence, and procedure manuals.
* Effectively present information and respond to questions from groups of managers, clients, customers, and the general public
* Work with mathematical concepts such as probability and statistics, especially in the areas of epidemiological and population statistics such as sensitivity, specificity, positive predictive values, etc.
* Apply concepts such as fractions, percentages, ratios, and proportions to practical situations
* Define problems, collect data, establish facts, and draw valid conclusions
* Interpret extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
* Manage client expectations; anticipate client requirements
* Support and contribute to DiaSorin Inc and the Commercial organizational revenue, process improvements and other goals
* Knowledge and understanding of medical terminology, anatomy, physiology, immunology, and immunoassay techniques
* Knowledge of FDA Quality System Regulations
* Thorough understanding of microbiology, immunology and testing for infectious disease
* Established presentation and training skills preferred
* Excellent written and verbal communication skills
* Strong interpersonal skills with an outgoing personality
* Self-motivated with a professional and engaged demeanor
* Organized with attention to detail
* Computer literate with Microsoft Word, PowerPoint, Excel, Google / Gmail platform
Working Conditions, Physical Demands, Travel, etc.
* Travel: 70-80%
* Exposure to biohazards and chemicals; Personal Protective Equipment (PPE) required
What we offer
Receive a competitive salary and benefits package as you grow your career at DiaSorin. Join our team and discover how your work can impact the lives of people all over the world.
We are an equal opportunity employer that values diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply.
This contractor and subcontractor shall abide by the requirements of 41 CFR 60-1.4(a), 41 CFR 60-300.5(a) and 41 CFR 60-741.5(a). These regulations prohibit discrimination against qualified individuals based on their status as protected veterans or individuals with disabilities, and prohibit discrimination against all individuals based on their race, color, religion, sex, sexual orientation, gender identity or national origin. Moreover, these regulations require that covered prime contractors and subcontractors take affirmative action to employ and advance in employment individuals without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.
DiaSorin Inc and DiaSorin Molecular LLC are Affirmative Action and Equal Opportunity Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Equal Employment Opportunity
Posters:https://www.dol.gov/agencies/ofccp/posters.
If you’d like to view a copy of the company’s affirmative action plan or policy statement, please email:. If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please e-mail:or call toll-free 1.800.328.1482.
