Clinical Lab Specialist
Pay $34 to $44 / hr based on experience
BS / BA / MA in Clinical Laboratory Science or Medical Technology, Biology Life Sciences or health related field required.
- Title Clinical Lab Specialist
10 panel drug test is required
It is our policy at Client that all Associates and Contract / Consultant employees who work with potentially infectious materials (i.e., blood) have their Hepatitis B vaccination or have been offered one by their employe Please review this with current contractors
We do not need to have the medical records, but need to know the following. Please keep all medical records confidential and in the safety of your company records.
Client requires documentation one of the following :
Hepatitis B vaccine has been offered and acceptedHepatitis B vaccine has been offered and rejectedContractor / Consultant has had previously been vaccinated for Hepatitis B and no further action takenContractor / Consultant has had previously been vaccinated for Hepatitis B and wants to have titer testing to ensure antibody statusVaccine has not been offeredThis 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 practices 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 Client 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 scienceExcellent verbal and written communications skillsAwareness / basic knowledge of GCP / GLP and ISO regulationsClinical 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 labPhlebotomy is a plusExperience with human blood specimen collection productsProduct Trouble shooting as it relates to clinical resultsStrong computer skillsStrong project planning and budget management skillsDevelop / implement new testing methodologies in collaboration with R&DProven 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 environment5 years experience in the Clinical Laboratory environment.
Salary : $34 - $44
