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    CLIA/Quality Assurance Manager - Hayward, United States - Bruker

    Bruker
    Bruker Hayward, United States

    1 day ago

    Default job background
    Description


    CLIA/Quality Assurance Manager



    Job Locations

    US-CA-Hayward

    ID



    # of Openings

    1

    Job Function

    Quality & Regulatory



    Overview



    Bruker is enabling scientists to make breakthrough discoveries and develop new applications that improve the quality of human life. Bruker's high performance scientific instruments and high value analytical and diagnostic solutions enable scientists to explore life and materials at molecular, cellular, and microscopic levels. In close cooperation with our customers, Bruker is enabling innovation, improved productivity, and customer success in life science molecular and cell biology research, in applied and pharma applications, in microscopy and nanoanalysis, as well as in industrial applications. Today, worldwide more than 8500 employees are working on this permanent challenge at over 90 locations.

    Bruker offers differentiated, high-value life science and diagnostics systems and solutions in preclinical imaging, clinical phenomics research, proteomics and multiomics, spatial and single-cell biology, functional structural and condensate biology, as well as in clinical microbiology and molecular diagnostics.

    Canopy Biosciences, a Bruker Company, is a rapidly growing and fast-paced biotechnology company with a CLIA certified laboratory located in Hayward, CA. We are committed to providing cutting-edge, multi-omics products and services to the academic and biotech research community. We are a team of dedicated scientists, passionate about our work and intent on making a difference in the pursuit of better drugs and technologies. Bruker Corporation has been driving innovation in analytical instrumentation for over 50 years. With more than 6,000 employees at over 70 locations worldwide, we are one of the world's leading analytical instrumentation companies supporting industries in successfully enhancing quality of life. We offer comprehensive benefits that give our employees the right environment where they can thrive and grow. We seek to hire a Clinical Lab Scientist (CLS) who would also serve as a CLIA-QA Manager for the Hayward site of Canopy Biosciences.

    The person would be responsible for conducting experimental and other activities required for supporting the CLIA laboratory. These include procedure writing, proper operation and maintenance of instruments, reagent qualification, quality control analysis, and maintaining documentation needed to ensure compliance with CLIA. The individual is expected to work independently and perform other related duties as needed to ensure a functioning clinical laboratory. As a QA manager the person is expected to work with Canopy Biosciences' QA team to ensure compliance of the Quality Management System for all non-clinical laboratory personnel. In this role the individual would be responsible for ensuring quality compliance and smooth functioning of the Hayward site.

    This is a part-time (estimated 24 hours/week) contract position (up to 12 months with possiblity to renew).



    Responsibilities



    Responsibilities may include, but are not limited to:

    Performing high complexity testing in the CLIA laboratory as needed
    * Maintaining all records required for regulatory compliance and supporting CLIA laboratory director with license renewal activities
    * Managing QA related activities for non-clinical service operations
    * As a member of the QA team interact with personnel throughout the organization to manage and ensure compliance of Quality Management System
    * Manage and support the internal document control system and update QMS documents as needed
    * Provide support for quality audits by service customers
    * Oversee and ensure compliance for all laboratory personnel training activities
    * Assist with identification and implementation of process improvements for quality compliance



    Qualifications



    B.A., B.S., M.A., or M.S. in biological science, medical technology, or related field
    * A current California State Clinical Laboratory Scientist (CLS) license is essential
    * Minimum of 3 years clinical laboratory experience as a CLS and/or QA specialist
    * Experience with molecular testing or regulatory compliance in a CLIA laboratory is a plus
    * Knowledge of clinical laboratory principles, procedures, practices, and instrumentation related to high complexity testing
    * Ability to work both independently and in a team-oriented setting
    * Familiar with quality assurance methods and procedures appropriate to a clinical laboratory

    At Bruker, base salary is part of our total compensation. The estimated base salary range for this full-time position is between $91,000 and $147,000. You will have the ability progress as you grow and develop within a role. The base salary for the role will depend on a several job-related factors, including, but not limited to education, training, experience, the geographic location of the successful candidate, skills, competencies, job-related knowledge and travel requirements for this position. Full-time employees may also be eligible for a full range of benefits including 401(k) with company match, an employee stock purchase plan, medical and dental plans, life insurance, short-term and long-term disability insurance, employee assistance program and paid time off including vacation, sick time and holidays, and more.

    Bruker is an equal-opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.

    Certain positions at Bruker require compliance with export control laws and as a result, all interviewed candidates for all positions will be screened pre-interview to determine their eligibility in light of export control restrictions.

    #LI-RD1

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