Jobs

    QA/RA Compliance Specialist - St. Petersburg, United States - Infojini

    Infojini
    Infojini St. Petersburg, United States

    2 weeks ago

    Default job background
    Description

    • Prepare and submit all federal, state and local permits in timely manner
    • Interact with Customers and gather information as needed to support registration activities
    • Assist in the preparation of standard operating procedures (SOPs) associated with job function; review and approve SOPs requiring the regulatory function participation under direction of the Group Leader
    • Assist in regulatory/health authority audits collecting information as requested.
    Collaborates with Subject Matter Experts (SME)s, management and supervisory personnel from applicable areas to resolve problems affecting product quality; collaboration includes investigating and CAPA initiation, following up on issues and a working jointly towards resolution

    • Prepare APRs in accordance with site procedures and timelines.
    • Prepare complaint investigation reports and work closely with others on site events to verify scope of investigations, assure root cause analysis and batch impact assessment are adequate, and recommend corrective actions to prevent deviation recurrence; ensure on time closure.
    • May author other types of quality system documents as directed or assigned by QA management.
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