at Sysmex America, Inc in Mundelein, Illinois, United States
Job Description
Specialist I, Scientific Assay
Job Location(s)
US-IL-Mundelein
# of Openings
1
Job ID
2024-3933
Category
Customer Care
Travel
None
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 an opportunity for a Specialist I, Scientific Assay. The Specialist, Scientific Assay is responsible for daily activities associated with the Sysmex America, Inc. Assay Lab and ensuring traceability of commercial blood products. The department will value assign control and calibrator products using industry traceable standards. The Lab will 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 other Sysmex reference labs colleagues and control manufacture to align lab processes and quality measures.
Essential Duties and Responsibilities:
1. Follow documented processes and procedures to determine consistently accurate and traceable assay values of commercial blood products used for daily QC and calibration by Sysmex customers. Establish and report such target values for QC materials according to production schedules.
2. Adhere to policies and procedures and maintain good laboratory practices. Document activities following ISO and FDA guidelines.
3. Demonstrate proficiency with reference methodologies and whole blood calibration process. Trend and review reference method results to ensure correct calibration of the Assay Lab analyzers.
4. Trend, monitor, and report on peer correlation of reference analyzers to ensure global traceability and comparability.
5. Analyze and review daily Quality Control and complete maintenance for each analyzer in the Assay Lab. Document all Sysmex analyzer activity in customer CRM. Ensure all equipment is calibrated following manufacturers, ISO, or FDA requirements.
6. Support continuous process improvement to identify waste, bottlenecks, and possible risks in department procedures. Support Lean Six Sigma methodologies within the department processes and monitoring of analyzer performance.
7. Assist with preparing annual plans for expenses and budgets, and provide monthly activity reports to management. Achieve all assigned Performance Management Objectives.
8. Maintain complete documentation of all processes applicable to the operation of the Assay 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. Ensure department quality by supporting an ongoing internal audit process.
9. Ensure comparability with the user base by supporting participation in CAP, API, and/or other assigned Proficiency Test surveys. Review and report any instruction, material, or comparability issues to department management.
Travel Percentage: 10%
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.
Qualifications
Associates degree and 5 years required experience in Hematology, and Hemostasis, including experience in the Armed Forces. Bachelor's degree in Clinical Laboratory Sciences preferred.
AMA or ASCP certification preferred.
Lean Six Sigma, troubleshooting and application skills preferred
English. Spanish, Portuguese, or French is a plus
All MS Office skills and some interface skills
Great attitude/personality, outstanding customer skills, good clinical laboratory practices.
Understanding of international standards and organizations.
Ability to apply knowledge from various disciplines, and provide directions that lead to solutions.
Ability to problem-solve, comprehensive research, investigation and analysis.
Ability to... For full info follow application link.
