Position : Clinical Lab Specialist

Location : Franklin Lakes, NJ

Duration : 12 Months contract

Total Hours/week : 40.00

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:

• Reporting to the Sr. Clinical Laboratory Manager in the Life Science segment for Integrated Diagnostic Solutions- Specimen Management.
• 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.

Responsibilities:

• Applies laboratory knowledge to manage complaint testing through design of testing methods to verify customer complaints.
• This includes interpreting complaints appropriately, designing relevant clinical testing to support the complaint.
• Execution of the testing with human blood using the appropriate laboratory equipment and drafting the testing summary based on the data and finding of the investigation.
• 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.

Position Requirements (as applicable):

Education:

• BS/BA/MA in Clinical Laboratory Science or Medical Technology, Biology Life Sciences or health related field required.

Licenses or certifications:

• MT/CLS (ASCP) or equivalent experience in a Research environment

Experience:

• 5years’+ experience in clinical laboratory science or in clinical research, product investigations, troubleshooting abnormal laboratory results and product development with clinical trials’ experience desired. Phlebotomy is a plus.

Special 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.

About Client:

Client, a leading global medical technology company that makes and sells medical devices, instrumented systems and reagents, is dedicated to improving people’s health throughout the world.

The Company’s capabilities are instrumental in combating many of the world’s most pressing diseases.

Founded in 1897 and headquartered in Franklin Lakes, New Jersey, Client employs more than 25,000 people in approximately 50 countries throughout the world.

The Company serves healthcare institutions, life science researchers, clinical laboratories, industry and the general public.

It was one of the first companies to sell U.S.-made glass syringes. It was also a pioneer in the production of hypodermic needles and ranked #195 in the 2019 Fortune 500 list.

It was also listed among the top 100 companies in Newsweek's 2009 Green Rankings. Ranking of the 500 largest American corporations based on environmental performance, policies, and reputation. Placed third in the health care sector and 83rd overall

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