Clinical Lab Specialist (Must Have Clinical Exp) - No Microbiology, Covid testers, Chemical lab
Company: millenniumsoft
Location: Franklin Lakes
Posted on: April 2, 2026
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Job Description:
Position : Clinical Lab Specialist (Must Have Clinical Exp) - No
Microbiology, No Covid testers, No Chemical lab Location : Franklin
Lakes, NJ Duration : 12 Months Total Hours/week : 40.00 1st Shift
Client: Medical Device Company Job Category: Healthcare Level Of
Experience: Mid-Level Employment Type: Contract on W2 (Need US
Citizens or GC Holders Only) Job Description: This laboratory-based
position will provide input to design, evaluation, execution and
reporting for safety and efficacy of new or modified in-vitro
diagnostic devices, as well as provide innovative ideas cross
functionally with other business units. Possess a technical
competence and works with human blood in clinical laboratory
disciplines such as phlebotomy, chemistry, hematology, coagulation,
urinalysis, point of care and capable operation of numerous
instrument platforms. Responsible for managing clinical laboratory
studies and complaint testing through a variety of clinical testing
methods. Knowledge and expertise demonstrating safety and efficacy
of new or modified in-vitro diagnostic devices, as well provide
innovative ideas outside of the core business. Develop/implement
new testing methodologies in collaboration with R&D.
Responsible for understanding product design, function and able to
apply quality and regulatory standards. Capable of performing
Clinical Software Validations (CSV) and all requirements for new
instrument validation/qualification as it relates to best practices
for the IQ/OQ/PQ in the clinical lab. Utilizes technical/scientific
judgment to resolve technical issues. Works with many different
disciplines (manufacturing, marketing, quality, regulatory, etc.),
materials, products, and processes in the development of core
clinical laboratory and outside the core clinical laboratory
products and services. Possesses a strong commitment to quality and
continuous improvement. Primary Duties, Responsibilities &
Authorities: Provides input to and conducts scientific
investigations in areas of considerable scope and complexity.
Explores, identifies, and recommends solution, concepts and
principles. Adapts methodologies as needed for areas related to the
core clinical laboratory. Conducts clinical testing, maintains
laboratory instrumentation/reagent test systems and inventory to
strategically align with the priorities within the lab and business
objectives. Implements and documents Quality Assurance and Quality
Control procedures as they pertain to instrumentation and
methodology. Conducts instrument verification per CLSI guidelines,
assists with updates and preparation of procedures and instrument
performance documentation in compliance with GLP and GCP. Performs
Clinical Software Validations (CSV) and all requirements for new
instrument validation/qualification as it relates to best practices
for the IQ/OQ/PQ in the clinical lab. Keeps current in the field of
Clinical Laboratory Science through review of technical literature,
participation in continuing education via webinars/symposia and or
customer visits. Trains new associates (permanent or temporary) on
the Laboratory workflow. Senses and monitors trends in laboratory
practice and utilizes this information to recommend new projects
and influence ongoing projects. Participates in development of the
clinical strategy for all client IDS- Specimen Management products
and is responsible for generation of scientific and clinical
information to support product conceptualization, feasibility, and
development. Responsible for scientific integrity and clinical
accuracy of all claims and communications made concerning specific
PAS products globally. Responsible for management of individual
focused projects to complex projects involving multiple internal
clinical studies/evaluations. This position provides support from a
base of clinical experience and knowledge to resolve customer
complaints through clinical investigations. This position will also
provide support to guide and implement innovation, product
development, clinical testing, manufacturing, and post market
surveillance via interfacing with R&D and GCD to insure
successful and timely completion of projects. Knowledge and Skills:
Strong working knowledge of clinical laboratory science Excellent
verbal and written communications skills Awareness/basic knowledge
of GCP/GLP and ISO regulations Clinical Software Validations (CSV)
and all requirements for new instrument validation/qualification as
it relates to best practices for the IQ/OQ/PQ in the clinical lab
Phlebotomy is a plus Experience with human blood specimen
collection products Product Trouble shooting as it relates to
clinical results Strong computer skills Strong project planning and
budget management skills Develop/implement new testing
methodologies in collaboration with R&D Proven understanding of
clinical laboratory testing, blood collection, Urinalysis, POC and
LIS/LIMS systems and an ability to apply knowledge to innovative
concepts/projects beyond the core clinical laboratory. Education
AND Experience: BS/BA/MA in Clinical Laboratory Science or Medical
Technology, Biology Life Sciences or health related field required.
MT/MLT CLS (ASCP) or equivalent experience in a Research
environment 5 years experience in the Clinical Laboratory
environment.
Keywords: millenniumsoft, New Brunswick , Clinical Lab Specialist (Must Have Clinical Exp) - No Microbiology, Covid testers, Chemical lab, Science, Research & Development , Franklin Lakes, New Jersey
