Clinical Lab Specialist

Insight Global is looking for a Clinical Lab Specialist for our Life Sciences and Med Device client in Franklin Lakes, NJ. This role will include the following:
- Design, evaluate, execute, and report on the safety and efficacy of in-vitro diagnostic devices.
- Conduct clinical testing and manage laboratory studies and complaint testing.
- Develop and implement new testing methodologies in collaboration with R&D.
- Perform Clinical Software Validations (CSV) and instrument validation/qualification.
- Maintain laboratory instrumentation and reagent test systems.
- Implement and document Quality Assurance and Quality Control procedures.
- Train new associates and stay current in Clinical Laboratory Science through continuing education.
- Resolve customer complaints through clinical investigations.
- Support innovation, product development, clinical testing, manufacturing, and post-market surveillance.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.

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- 1-5+ years in a Clinical Laboratory environment
- Strong knowledge of clinical laboratory science.
- Excellent verbal and written communication skills.
- Experience testing medical instruments (syringes, catheters, etc)
- Experience processing specimens within the hematology, clinical chemistry, and urinalysis spaces
- Awareness of GCP/GLP and ISO regulations.
- Experience with human blood specimen collection products.
- Strong computer skills and project planning/budget management skills.
- BS/BA/MA in Clinical Laboratory Science, Medical Technology, Biology Life Sciences, or a related health field.

- MT/MLT CLS (ASCP) or equivalent experience in a research environment.

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.