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Specialist QA

    Specialist QA - Juncos, Puerto Rico - Integrated Services For Productivity & Validation, Inc

    Integrated Services For Productivity & Validation, Inc
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    Descripción
    Qualified candidates please review the required expertise;

    • Perform Trackwise system queries, deviations

    • Participate in triage process

    • Perform oversight of the process and procedures/GMP tasks

    • Manage Change Controls and deviations for review and approval as QA contact

    • Work with operations to resolve basic compliance discrepancies

    • Knowledge in Validations and Laboratory area and equipment

    • Strong organizational skills, including ability to follow assignments through to completion.

    • Enhanced skills in leading, influencing and negotiating with the ability to interact with regulatory agencies and evaluate compliance issues.

    • Microsoft Office spreadsheet and application skills and presentation knowledge.

    • Strong communication (both written and oral), facilitation and presentation skills. Fully Bilingual in English and Spanish.

    • Validated skill in working independently and to optimally interact with all levels throughout the organization.

    Requirements

    Education and years of experience;
    • Doctorate degree or Master's degree and 3 years of directly related experience
    • or Bachelor's degree and 5 years of directly related experience
    • or Associate's degree and 10 years of directly related experience
    • or High school diploma / GED and 12 years of directly related experience.

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