Clinical Lab Specialist

Immediate need for a talented Clinical Lab Specialist. This is a 12+ Months Contract opportunity with long-term potential and is located in Franklin Lakes, NJ (Onsite). Please review the job description below and contact me ASAP if you are interested.

Job ID:25-54748

Pay Range: $30 - $38/hour.  Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
 
Key Responsibilities:

• 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 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.

Key Requirements and Technology Experience:

• Skills-Blood Plasma, Clinical Lab Experience , ASCP, MLT , MLS.
• 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.
• 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.

Our client is a leading Healthcare Industry and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.
 
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