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Full-time
Seattle, WA 98102
Updated 25 days ago
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Kelly Science and Clinical is the world’s most recognized brand in science and clinical staffing with more than 100 locations in North America, Europe and the Pacific Rim. Our scientists contribute to the research and development of the next generation of small molecule drugs, biologics and cellular therapies.

Overview

Provide technical functions and support for CLIA/CAP regulated high complexity clinical laboratory performing molecular testing using NGS; and assist with maintenance of laboratory compliance.


Responsibilities

  • Provides review of assay QC data for trials and research studies, and first review of patient QC data (for subsequent review and approval by an individual qualified as a Clinical Laboratory Director)
  • Assists with technical trouble-shooting and related quality improvement initiatives
  • Develops, monitors and trends quality metrics and prepares monthly reports for review and approval by a Clinical Laboratory Director
  • Authors and/or reviews laboratory requirement documents (e.g., Analytic Methods, SOPs) for approval by a Clinical Laboratory Director
  • Reviews quality control and maintenance logs for completeness and accurate documentation
  • Supports assessment of non-conformances and escalates to a Clinical Laboratory Director when there is a potential for impact to patient care
  • Supports LIMS Development in collaboration with the software team (e.g., creates dashboards for tracking and prioritizing requests, generates user requirements, UAT cases and plans, completes test plans, and related documents for system features and enhancements)
  • Assigns and monitors timely, accurate completion of proficiency testing for review and approval by the Clinical Laboratory Director
  • Collaborates with Clinical Laboratory Directors to develop and continuously improve day-to-day operations and ensure cross-functional alignment with laboratory support groups
  • Support and initiate activities, in conjunction with the Laboratory Technical Supervisor or Clinical Laboratory Directors to ensure laboratory compliance with applicable regulations
  • Note that all responsibilities are to be defined to align with the definition of a Technical Supervisor under CLIA and NYS CLEP. All functions of at Technical Supervisor under CAP require oversight by a Clinical laboratory Director.

Qualifications

Required 

  • A bachelor’s, master’s, or  PhD in a chemical, physical, biological or clinical laboratory science from an accredited institution; and at least seven years of laboratory training or experience in high complexity testing for clinical molecular pathology/genetics under the direct or indirect supervision of a board-certified clinical laboratory director.
  • Molecular biology techniques (DNA extraction, PCR, Next-generation sequencing [NGS]), laboratory automation, Laboratory information management systems, reagent and instrument qualification, NGS data analysis, CAP/CLIA regulations.

Preferred

  • Experience reviewing Illumina sequencer analytics
  • Strong communication and interpersonal skills
  • Advanced critical thinking and problem-solving skills
  • Ability to work in a team environment
  • Promotes a positive work environment while supporting management and business goals
  • Experience within regulated GxP laboratory environment
  • Ability to collaborate across teams and disciplines
  • Creates a productive and professional culture
  • Upholds clinical laboratory best practices; and complies with applicable regulations.

#TJP2021_SPEC



Why Kelly®?

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

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