Clinical Lab Specialist (No Microbiology, No Covid testers, No Chemical lab)

Position

Clinical Lab Specialist (No Microbiology, No Covid testers, No Chemical lab)

Description

Position : Clinical Lab Specialist (No Microbiology, No Covid testers, No Chemical lab) Location : Franklin Lakes, NJ Duration : 12 Months Total Hours/week : 40.00 1st Shift Client: Medical Device Company Job Category: Healthcare Level Of Experience: Mid-Level Employment Type: Contract on W2 (Need US Citizens or GC Holders Only)

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. - 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. - 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. - Responsible for supporting customer complaints through clinical investigations. - Supports innovation, product development, clinical testing, manufacturing, and post market surveillance via interfacing with R&D and GCD to ensure successful and timely completion of projects.

Knowledge and 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.

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 environment - 5 years+ experience in the Clinical Laboratory environment.