Amerit Consulting
Overview
Clinical Lab Specialist position for a US Fortune 250 medical technology company. Onsite role at 1 Becton Drive, Franklin Lakes, NJ 07417. Duration: 12 months +. 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, and will contribute innovative ideas cross-functionally with other business units. Role includes technical work in clinical laboratory disciplines such as phlebotomy, chemistry, hematology, coagulation, urinalysis, point of care, and operation of instrument platforms. Responsible for managing clinical laboratory studies and complaint testing through various clinical testing methods. Develop/implement new testing methodologies in collaboration with R&D. Understand product design and apply quality and regulatory standards. Perform Clinical Software Validations (CSV) and requirements for new instrument validation/qualification (IQ/OQ/PQ) in the clinical lab. Resolve technical issues using scientific judgment. Collaborate with multiple disciplines (manufacturing, marketing, quality, regulatory, etc.). Maintain a strong commitment to quality and continuous improvement. Provide input to scientific investigations of considerable scope and complexity and identify solutions and concepts. Adapt methodologies for areas related to the core clinical laboratory. Conduct clinical testing, maintain laboratory instrumentation/reagent test systems, and manage inventory aligned with lab and business priorities. Implement and document Quality Assurance and Quality Control procedures for instrumentation and methodology. Conduct instrument verification per CLSI guidelines; assist with updates and preparation of procedures and instrument performance documentation in compliance with GLP and GCP. Maintain current knowledge in the field of Clinical Laboratory Science through literature review, continuing education, and customer visits. Train new associates on laboratory workflow (permanent or temporary). Monitor trends in laboratory practice and propose new projects to influence ongoing work. Participate in the development of clinical strategy for IDS-Specimen Management products and generate scientific/clinical information to support concept development and feasibility. Ensure scientific integrity and clinical accuracy of all claims and communications concerning PAS products globally. Manage projects ranging from focused to complex with multiple internal clinical studies/evaluations. Provide clinical support to resolve customer complaints through investigations and collaboration with R&D and GCD to ensure timely project completion. 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 of 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 (IQ/OQ/PQ) in the clinical lab. Phlebotomy is a plus. Experience with human blood specimen collection products. Product troubleshooting as it relates to clinical results. Strong project planning and budgeting 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 ability to apply knowledge to innovative concepts/projects beyond the core clinical laboratory. Amerit Consulting is an equal employment opportunity employer. Applicants will be considered for employment without attention to race, color, religion, sex, national origin, disability, or any other protected status. Applicants with criminal histories are considered in accordance with local, state and federal laws. Seniority level
Mid-Senior level Employment type
Contract Job function
Science, Other, and Quality Assurance Industries Medical Equipment Manufacturing
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Clinical Lab Specialist position for a US Fortune 250 medical technology company. Onsite role at 1 Becton Drive, Franklin Lakes, NJ 07417. Duration: 12 months +. 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, and will contribute innovative ideas cross-functionally with other business units. Role includes technical work in clinical laboratory disciplines such as phlebotomy, chemistry, hematology, coagulation, urinalysis, point of care, and operation of instrument platforms. Responsible for managing clinical laboratory studies and complaint testing through various clinical testing methods. Develop/implement new testing methodologies in collaboration with R&D. Understand product design and apply quality and regulatory standards. Perform Clinical Software Validations (CSV) and requirements for new instrument validation/qualification (IQ/OQ/PQ) in the clinical lab. Resolve technical issues using scientific judgment. Collaborate with multiple disciplines (manufacturing, marketing, quality, regulatory, etc.). Maintain a strong commitment to quality and continuous improvement. Provide input to scientific investigations of considerable scope and complexity and identify solutions and concepts. Adapt methodologies for areas related to the core clinical laboratory. Conduct clinical testing, maintain laboratory instrumentation/reagent test systems, and manage inventory aligned with lab and business priorities. Implement and document Quality Assurance and Quality Control procedures for instrumentation and methodology. Conduct instrument verification per CLSI guidelines; assist with updates and preparation of procedures and instrument performance documentation in compliance with GLP and GCP. Maintain current knowledge in the field of Clinical Laboratory Science through literature review, continuing education, and customer visits. Train new associates on laboratory workflow (permanent or temporary). Monitor trends in laboratory practice and propose new projects to influence ongoing work. Participate in the development of clinical strategy for IDS-Specimen Management products and generate scientific/clinical information to support concept development and feasibility. Ensure scientific integrity and clinical accuracy of all claims and communications concerning PAS products globally. Manage projects ranging from focused to complex with multiple internal clinical studies/evaluations. Provide clinical support to resolve customer complaints through investigations and collaboration with R&D and GCD to ensure timely project completion. 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 of 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 (IQ/OQ/PQ) in the clinical lab. Phlebotomy is a plus. Experience with human blood specimen collection products. Product troubleshooting as it relates to clinical results. Strong project planning and budgeting 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 ability to apply knowledge to innovative concepts/projects beyond the core clinical laboratory. Amerit Consulting is an equal employment opportunity employer. Applicants will be considered for employment without attention to race, color, religion, sex, national origin, disability, or any other protected status. Applicants with criminal histories are considered in accordance with local, state and federal laws. Seniority level
Mid-Senior level Employment type
Contract Job function
Science, Other, and Quality Assurance Industries Medical Equipment Manufacturing
#J-18808-Ljbffr