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    Quality Assurance Specialist - San Jose, United States - Medix™

    Medix™
    Medix™ San Jose, United States

    1 week ago

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    Description

    Primary Responsibilities:

    Perform investigations per established procedures

    Support problem solving and troubleshooting as part of investigations

    Generate quality records as needed (CAPAs, CCs) to support process improvements

    Review laboratory records (test packets, logbooks, etc.) and ensure they have

    acceptable Good Documentation Practices and are following procedures

    Update and draft standard operating procedures and work instructions

    Communicate effectively with all team members

    Minimum Qualifications:

    Bachelor's Degree in a scientific, engineering, or other technical discipline

    4 years of experience in a quality assurance setting

    Direct experience in record review, investigations, and root cause analysis

    Good understanding and compliance with principles of Good Documentation Practices

    Strong organizational and time management skills

    Excellent attention to detail

    Strong analytical skills

    Succeed when working independently and as part of a team

    Demonstrated work ethic and accountability

    Preferred Qualifications:

    Experience working within a quality system (e.g. Veeva)

    Thrive in a fast paced, growing, and dynamic work environment

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