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.
• 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 BD 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.
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.
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.
Description:
he statements below are intended to describe the general nature and level of work being performed by associates assigned to this job. This job description is not intended to be an exhaustive list of all responsibilities, duties, and skills required of associates so classified.
...care. This position also uses multiple computer applications and works in a fast-paced remote environment. Responsibilities... ...financial well-being. ~ Comprehensive medical, dental, vison, life insurance, and legal services available first day of the month after hire...
...Wines is a portfolio of highly acclaimed wines and spirits from some of the worlds greatest estates. The company owns more than 24 wineries and a distillery, each with its distinct style, legacy, and approach to hospitality. Job Summary: Silverado Vineyards seeks...
**Job Overview:** We are looking for a reliable Virtual Assistant to help apply for US-based remote software engineering jobs. You will use our internal resume tailoring tool to generate customized resumes and submit applications across multiple platforms. **Responsibilities...
...BSA Analyst To $42/hr ($500 Hiring Bonus) Joliet, IL (Temp-To-Perm) Job # 3579 Who We Are The Symicor Group is a boutique talent acquisition firm based in Schaumburg, IL & Rockport, TX. Our nationally unique value proposition centers around providing the very...
..., remote/telecommute Position: Virtual Assistant Services & Remote Personal Assistants Naplesjetcenter is a leading private aviation company based in Naples, Florida. We are currently seeking highly motivated and organized individuals to join our team as Virtual...