161101 - Clinical Laboratory Specialist – Onsite – $39.58 / hr

Job Title : Clinical Laboratory Specialist – Onsite – $39.58 / hr

Location : Franklin Lakes, NJ (Onsite, Monday–Friday, 8 : 30 AM–5 : 00 PM)

Pay Rate : $39.58 / hr

Employment Type : Contract (potential extension / long-term)

Shift : 1st shift, full-time, onsite

Position Summary :

We are seeking a Clinical Laboratory Specialist to join our diagnostic development team in Franklin Lakes, NJ. This laboratory-based role works directly with human blood and related materials. You will support the design, evaluation, and reporting of in-vitro diagnostic devices, ensuring compliance with regulatory standards and contributing innovative ideas to improve testing methodologies.

Key Responsibilities :

Conduct clinical testing and manage laboratory studies, including complaint testing

Maintain and operate lab instrumentation across multiple disciplines (chemistry, hematology, urinalysis, coagulation, point-of-care)

Implement and document Quality Control and Quality Assurance procedures

Perform Clinical Software Validations (CSV) and instrument validation / qualification (IQ / OQ / PQ)

Support development and evaluation of new diagnostic devices and methodologies

Train new team members on lab workflows

Collaborate with R&D, quality, regulatory, and manufacturing teams

Provide clinical input on strategy, documentation, and regulatory submissions

Investigate and resolve technical issues with clinical products and processes