Specialist II, Laboratory - Operations - RACA

Company: Sysmex America, Inc
Location: Mundelein
Posted on: May 25, 2023

Job Description:

Specialist II, Laboratory - Operations - RACA



Job Location(s)

US-IL-Mundelein





# of Openings

1



Job ID

2023-3391



Category

Regulatory/Quality



Travel

40






































Overview









Find a Better Way... ...to use your skills and experience. This is the time to let your talent come to life. To maximize your knowledge and use it for the greater good. To work with the best professionals using state-of-the-art technology, and improve lives with your innovative ideas and ambitious dreams. Find a better way: the Sysmex Way. ...to improve the lives of others. Headquartered in Kobe, Japan, Sysmex is located in Lincolnshire, Illinois. Renowned worldwide for the very finest in quality, innovative diagnostic equipment and information-management systems, we apply science to enhance the quality of life on a global scale. Our agile, resourceful team is committed to realizing critical breakthroughs in laboratory diagnostics, information technology, workflow analysis and life sciences for the clinical laboratory. ...to build a promising future.













Responsibilities









We currently have a great opportunity available for a Specialist II, Laboratory - Operations - RACA. The Laboratory Specialist II will work with the Regulatory and Clinical Affairs (RACA) Laboratory to support both in-house and external clinical studies. Strong background in one of the following three areas is preferred: Urinalysis, Flow Cytometry or Immunoassays. The Laboratory Specialist II will ensure equipment and supplies ship to Clinical Study sites in a timely manner to meet scheduled installation and training timelines. Essential Duties and Responsibilities: 1. Perform testing on prototype, investigational use and on-market clinical laboratory instruments, software, reagents and controls manufactured by Sysmex America Incorporated (SAI) and similar instruments and products. Adhere to established procedures, study-specific protocols and timelines.
2. Evaluate the Investigational Use Only (IUO) instruments according to Instructions for Use / package inserts. Learn to operate comparator and/or screening devices and confirmatory tests.
3. Perform routine laboratory functions such as; run QC with appropriate frequency, perform and properly document preventative maintenance, monitor laboratory supplies (consumables, reagents, controls, chemicals, etc.).
4. Become an instrument and/or troubleshooting resource both internally and externally (clinical sites). Attend service training to learn to service in house analyzers.
5. Responsible for maintaining clinical inventory records. Work with Customer Care to document location of analyzers when moved to and from Clinical Study sites.
6. Arrange shipment of analyzers and reagents with transportation and TPMs. Must have ability to move, pack and lift Clinical Analyzers.
7. Travel to Clinical Study sites and assist TPM with installation and calibration activities, ensure QC performs within established limits. Return to site at end of study to de-prime and prepare study instruments for return to Sysmex.
8. Act as on-site support for Clinical Research Associates.
9. Follow all Sysmex policies for safety, environment and infection control.
10. Other duties, as assigned. Physical Risk: Regular exposures to risk that may require special training and precautions. Physical Demands: Heavy physical activity. Routine handling of objects more than 50 pounds. May require periods of substantial discomforts due to excessive noise, dust, and/or other conditions.
Travel Percentage: 40%













Qualifications

• Bachelor's degree and 5_ years Laboratory experience in electronic medical equipment required, including experience in the Armed Forces. Bachelor's degree with a specialization in Medical Technology preferred.
• Proficient in Microsoft Office (Word, Excel, Power Point).
• Clinical Applications or Training experience is a plus. Sysmex's COVID-19 vaccination policy, consistent with its status as a federal government contractor and commitment to its customers and to providing a safe workplace for its employees, requires that, to the extent permitted by applicable law, all Sysmex employees must be fully vaccinated against COVID-19 by the latter of your start date. To the extent permitted by applicable law, any offer of employment extended will be conditioned upon the individual's ability to provide proof of current vaccination status. Sysmex makes reasonable accommodations when needed for medical or religious reasons. However, vaccine exemption and other accommodation requests cannot be granted unless the individual is able, with the accommodation, to perform the essential functions of the job. Sysmex is proud to be an EEO/Affirmative Action employer. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, age, sex, sexual orientation, gender identity or expression, color, religion, national origin, genetics, disability status, protected veteran status or any other characteristic protected by law. We maintain a drug-free workplace and perform pre-employment substance abuse testing.
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  

Keywords: Sysmex America, Inc, Arlington Heights , Specialist II, Laboratory - Operations - RACA, Healthcare , Mundelein, Illinois