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Quality Assurance and Safety SpecialistKelly Science is seeking a Quality Assurance and Safety Specialist to join a world leader in genetic diagnostics and gene therapy research. This candidate will be responsible for maintaining and assessing the Laboratory's QA, QI indicators, and safety programs while following regulations set forth by CLIA and other regulatory agencies.Primary Duties & Responsibilities:
Works with the Laboratory Director, Chief laboratory Officer, Operations Manager, supervisors and other staff in coordinating QA activities of the labs.
Maintains up-to-date knowledge and understanding of requirements and regulations set forth by CLIA and other regulatory agencies, FDA, Occupational Safety and Health Administration and Center for Disease Control.
Maintains inspection readiness and assist with internal and external audits by regulatory and accrediting agencies
Responsible for assessing patient test management in the pre-analytic, analytic and post-analytic processes, review and compilation of complaints and incident reports, and corrective actions.
Responsible for facilitating any required documentations for new or renewal of laboratory licenses and certificates for CDPH, CMS, etc.
Ensures that appropriate follow up on corrective action is implemented when test result/s is found unsatisfactory.
Prepares and conducts quarterly QA and Safety meeting
Serves as a source of reference for regulations pertaining to laboratory safety, chemical hygiene and safe disposal of chemical and biohazardous materials.
Creates safety training programs that promotes safe practices within the laboratory and employee knowledge of the hazards and possible exposures inherent to the work in the clinical and anatomic pathology laboratory
Responsible for the planning, development and standardization of the Safety Manuals, Chemical Hygiene Plan, Exposure Control Plan and Infection Control Plan consistent with legal requirements and company policies and procedures.
Maintain document control system for the creation, review, and revision of laboratory administrative and safety policies and procedures.
Education and Experience:
Bachelor's degree in a work-related discipline/field.
Minimum of four years of directly related work experience.
Must have CLIA lab working experience.
License/Certification: Clinical Lab Scientist (CLS) preferred but not required
Why Kelly ® ?Kelly® Science 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. 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. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
Vacancy expired!