• Clinical Compliance Auditor

    Astrix Technology (Los Angeles, CA)


    Clinical Compliance Auditor

     

    Clinical

     

    Los Angeles, CA, US

    Pay Rate Low: 100000 | Pay Rate High: 150000

    + Added - 04/04/2025

     

    Apply for Job

     

    We're partnering with an innovative client in the biotechnology industry, and they're on the lookout for a talented **Clinical Compliance Auditor** to join their dynamic team! If you're passionate about ensuring the highest standards in clinical trials and want to make a real impact, this is the opportunity for you. Don’t wait—apply today and take the next step in your career

     

    **Salary:** $100,000-$150,000

    **Location:** Remote

    Responsibilities:

    + Oversee and regularly update the Clinical Trial Quality Management system to ensure alignment with current industry standards, guidelines, and best practices.

    + Assist in the creation and evaluation of standard operating procedures (SOPs) and other essential controlled documents, such as forms, templates, and work instructions.

    + Ensure adherence to SOPs and compliance with relevant standards, including ICH GCP E6 (R2).

    + Lead the incident management process by tracking and addressing complaints, deviations, and corrective actions (CAPAs).

    + Organize, coordinate, and execute audits of vendors, suppliers, clinical trial sites, as well as internal and compliance audits, including for-cause audits.

    + Prepare necessary documentation to support audit activities, including audit plans, reports, certificates, and corrective action plans.

    + Verify the accuracy of audit findings and follow-up activities, ensuring non-compliance issues are resolved appropriately.

    + Review and finalize audit reports for accuracy and completeness.

    + Examine trial-related documents such as protocols, amendments, informed consent forms (ICFs), pharmacy manuals, and clinical study reports (CSRs).

    Requirements:

    + Bachelor's or Master's degree in a life sciences or engineering discipline

    + 4-7 years of experience in a GCP-Biologics or pharmaceutical environment.

    + CQA or other audit certifications are desirable.

    + Previous experience with TMF or electronic document management systems is a plus.

     

    We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.