Website CYNET SYSTEMS
CYNET SYSTEMS
Company : CYNET SYSTEMS
Job Description:
Pay Range: $50.57hr – $53.57hr
- The Clinical Laboratory Scientist conducts and oversees complex scientific investigations within the clinical laboratory, ensuring high-quality results and compliance with regulatory standards.
- This role involves developing methodologies, performing validations, supporting product development, and maintaining scientific integrity across laboratory operations.
Responsibilities:
- Provide input to and conduct scientific investigations of considerable scope and complexity.
- Explore, identify, and recommend solutions, concepts, and principles to improve laboratory operations.
- Adapt methodologies as needed for areas related to the core clinical laboratory.
- Conduct clinical testing and maintain laboratory instrumentation, reagent systems, and inventory in alignment with business priorities.
- Implement and document Quality Assurance and Quality Control procedures for instrumentation and methodology.
- Perform instrument verification following CLSI guidelines and assist with documentation in compliance with GLP and GCP.
- Conduct Clinical Software Validations (CSV) and new instrument qualification/validation (IQ/OQ/PQ) according to clinical lab best practices.
- Stay current in Clinical Laboratory Science through ongoing education and literature review.
- Train new laboratory associates on workflow, techniques, and compliance requirements.
- Monitor laboratory trends to recommend and influence ongoing and future projects.
- Participate in the development of clinical strategies for Specimen Management products and contribute to product conceptualization and development.
- Ensure scientific integrity and clinical accuracy in all product-related claims and communications.
- Manage individual and complex multi-study clinical projects.
- Support customer complaint resolution through clinical investigations.
- Collaborate with R&D and GCD teams to guide innovation, clinical testing, manufacturing, and post-market surveillance activities.
Skills:
- Strong working knowledge of clinical laboratory science.
- Excellent verbal and written communication skills.
- Understanding of GCP, GLP, and ISO regulations.
- Experience in Clinical Software Validation (CSV) and instrument qualification/validation (IQ/OQ/PQ).
- Phlebotomy skills are a plus.
- Experience with human blood specimen collection products.
- Troubleshooting skills related to clinical results.
- Strong computer, project planning, and budget management skills.
- Ability to develop and implement new testing methodologies with R&D collaboration.
- Solid understanding of clinical laboratory testing, blood collection, urinalysis, POC, and LIS/LIMS systems.
Qualification and Education:
- BS/BA/MA in Clinical Laboratory Science, Medical Technology, Biology, Life Sciences, or a related field (required).
- MT/MLT CLS (ASCP) certification or equivalent research experience.
- Minimum of 5 years of experience in a clinical laboratory environment.