Specialist, Hemostasis Lab

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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.

We currently have a great opportunity available for a Hemostasis Lab Specialist. The Specialist, Hemostasis Lab is responsible for daily activities associated with the Sysmex America, Inc. Hemostasis Lab. The Lab will provide control and reagent testing, control, trend, calibrate, and maintain the reference analyzers and methods to meet ISO and FDA standards. Quality of the department and value assignment process will be measured and maintained above 5 Sigma quality. The Specialist will work with the Sysmex America, Inc Assay Lab and other Sysmex reference labs colleagues and control manufacture to align lab processes and quality measures.

Essential Duties and Responsibilities:

1. Maintain processes and procedures to determine consistently accurate and verifiable assay values. Establish and report such target values for QC materials in a timely manner. Test and maintain correlation to suitable reference methods. Test reagent lot numbers. Maintain good laboratory practices and adhere to policy and procedures including a strict schedule for timely maintenance and calibrations. Document activities following ISO and FDA guidelines.
2. Analyze and review daily Quality Control and complete maintenance for each analyzer in the Hemostasis Lab. Document all Sysmex analyzer activity in customer CRM (IFS). Maintain Master Equipment list and ensure all equipment is calibrated following manufacturers, ISO, or FDA requirements.
3. Support complaint investigations and customer inquiries.
4. Assist the SAI Assay Lab with Hematology processes and procedures to ensure consistent accurate and verifiable assay values. Establish and report such target values for QC materials used in the Sysmex IQAP program in a timely manner. Demonstrate proficiency with reference methodologies and whole blood calibration process.
5. Demonstrate proficiency with reference methodologies. Support reference analyzers trending activities.
6. Trend, monitor, and report on peer correlation of reference analyzers to ensure global traceability and comparability.
7. Support Lean Six Sigma methodologies within the department processes and monitoring of analyzer performance. Support continuous process improvement to identify waste, bottlenecks, and possible risk in department procedures.
8. Assist with preparing annual plans for expenses and budgets, and provide monthly activity reports to management. Achieve all assigned Performance Management Objectives.
9. Maintain full and complete documentation of all processes applicable to the operation of the Hemostasis lab, and ensure such procedures are in full compliance with the general policies governing Sysmex America Inc.’s Quality management System and with the framework established by ISO 9001:2000. To ensure department quality support an ongoing internal audit process.
10. Support participation in CAP and or other assigned Proficiency Test surveys to ensure comparability with user base. Review and report any issues with instruction, material, or comparability to department management.

Percentage of Travel: 10% or less

Physical Risk: Regular exposures to risk that may require special training and precautions.

Physical Demands: Moderate physical activity. Routine handling of objects 21 to 50 pounds; continuous (at least 80% of time) walking or inspections, keyboard or CRT work. May require periods of moderate discomfort due to noise, dust, lighting and/or other conditions.

• Bachelor's degree in medical laboratory sciences or life sciences, with 2-4 years’ clinical laboratory experience in Hemostasis required, including experience in the Armed Forces. Phlebotomy experience preferred.
• AMT or ASCP certification. Medical Technologist, Medical Laboratory Scientist, Medical Laboratory Technician, or Clinical Laboratory Scientist
• Lean Six Sigma, troubleshooting and application skills preferred

• English. Spanish, Portuguese, or French is a plus

• All MS skills and some interface skills

• Be able to explain and interpret complex information that requires patience and understanding.

• Great attitude/personality, outstanding customer skills, good clinical laboratory practices, project management, and team leader skills.

• Understanding of international standards and organizations.

• Ability to make recommendations and define actions in a clear and concise way.

• Ability to lead projects and teams to achieve corporate goals.

• Ability to apply knowledge from various disciplines, and provide directions that lead to solutions.

• Ability to problem-solve comprehensive research, investigation, and analysis.

This job requires satisfaction of the credentialing requirements of Sysmex’s customers, including hospitals and other healthcare facilities, which generally includes proof of current vaccinations for measles, mumps, rubella, varicella (chicken pox), and COVID-19.  Further, 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 to the extent permitted by applicable law.  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 including working at customer locations. 

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.