Job Description

OVERVIEW :

Our client, a US Fortune 250 company and a global medical technology corporation serving customers in Clinical Labs, Health care research & Pharmaceutical industry, seeks an accomplished Clinical Lab Specialist.

** JOB ID: 52448

** JOB TITLE: Clinical Lab Specialist

** LOCATION: Onsite Role 1 Becton Drive Franklin Lakes, NJ 07417

** DURATION: 12 months +

Pay Rate: $40.00/hr. - $44.00/hr. (depending upon experience)

JOB RESPONSIBILITIES:

• 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.
• 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.

JOB REQUIREMENTS:

• Education: 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
• 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

I'd love to talk to you if you think this position is right up your alley, and assure a prompt communication, whichever direction. If you are looking for rewarding employment and a company that puts its employees first, we'd like to work with you.

Recruiter Name: Lalit Malgotra

Title: Lead Recruiter

Email ID: lmalgotra@ameritconsulting.com

Company Overview:

Amerit Consulting is an extremely fast-growing staffing and consulting firm. Amerit Consulting was founded in 2002 to provide consulting, temporary staffing, direct hire, and payrolling services to Fortune 500 companies nationally: as well as small to mid-sized organizations on a local & regional level. Currently, Amerit has over 2,000 employees in 47 states. We develop and implement solutions that help our clients operate more efficiently, deliver greater customer satisfaction, and see a positive impact on their bottom line. We create value by bringing together the right people to achieve results. Our clients and employees say they choose to work with Amerit because of how we work with them - with a service that exceeds their expectations and a personal commitment to their success. Our deep expertise in human capital management has fueled our expansion into direct hire placements, temporary staffing, contract placements, and additional staffing and consulting services that propel our clients’ businesses forward.

Amerit Consulting provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Applicants with criminal histories are considered in a manner that is consistent with local, state and federal laws.

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