Job Title:  Clinical Lab Specialist
Location: Franklin Lakes, NJ (Monday – Friday, 8:30 AM – 5:00 PM)
Duration: 12 months
Possibility of extension

Role Overview 

•  Perform testing to evaluate the safety and efficacy  of new or modified in-vitro diagnostic devices.
•  Work directly with  human blood samples  in multiple lab disciplines.
•  Conduct clinical studies, complaint testing, and support product troubleshooting.
•  Perform instrument verification, software validations, and ensure compliance with CLSI, GLP, and GCP guidelines.
•  Develop and implement new testing methodologies in collaboration with R\&D.
•  Maintain lab instrumentation, reagents, and quality systems.
•  Train new lab staff and keep up to date with industry standards and best practices.
•  Support projects from  product development  to  post-market surveillance  by providing scientific and clinical expertise.

Technical Skills: 

• Hands-on experience in phlebotomy, hematology, chemistry, coagulation, urinalysis, and point-of-care testing.
• Strong knowledge of GLP/GCP, ISO regulations, and laboratory best practices.
• Skilled in instrument validation (IQ/OQ/PQ), Clinical Software Validations (CSV), and troubleshooting lab results.
• Familiarity with LIS/LIMS systems and lab instrumentation.
• Vaccination Requirement:  Since this role involves working with human blood.

Candidates must provide documentation confirming one of the following:

•  Hepatitis B vaccine has been  offered and accepted 
•  Hepatitis B vaccine has been  offered and declined 
•  Candidate has  previously been vaccinated  for Hepatitis B (no further action needed)
•  Candidate has been vaccinated and requests  titer testing  for antibody status
•  Vaccine has  not yet been offered 

Key Requirements: 

• Education:  BS/BA/MA in Clinical Laboratory Science, Medical Technology, Biology, Life Sciences, or a related field.
• Licensing:  Valid MT/MLT CLS (ASCP) license that covers the full length of the assignment (copy required before interview).
• Experience:  Minimum 5 years in a clinical laboratory environment.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 47.00/hr.