• QA Coordinator III – Supplier & cGMP

    Job Locations US-AZ-Gilbert
    Job ID
    2018-2513
    Category
    QRTS
  • Position Summary

    This position oversees all activities relating to the Supplier Qualifications and cGMP facility audits. Provides management briefings and timely reports reflecting the status of all supplier qualifications and audit activities. Schedules and plans work for internal and external audits. Assists in the development and revision of department policies and procedures. Ensures that audit activities and corrective actions are completed, documented and that records are current.

    Essential Duties & Responsibilities (Other duties may be assigned)

    • Collaborate with internal departments regarding the contract manufactures meeting the requirements of the Supplier Qualification Program.
    • Perform manufacturing facility audits to ensure consistency to internal processes, Isagenix requirements and regulatory compliance.
    • Maintain working knowledge of 21 CFR parts 110/117, 111, etc.
    • Prepare, issue, and track reports of observations noted during audits and inspections.
    • Maintain computerized files to support audit activities.
    • Coordinate Audit Schedules of manufacturing, laboratory facilities, and internal audits.
    • Work with manufacturing and laboratory contract manufacturers and laboratories to schedule audits and manage any corrective actions resulting from the audit observations.
    • Perform internal audits.
    • Review and update internal Quality SOPs to ensure reflection of current practices.

    Minimum Qualifications (These are the requirements that all applicants MUST HAVE to be considered for this position)

    • Bachelor’s degree from an accredited institution in a life science related field required) or equivalent quality assurance experience.
    • 4 years of Quality Assurance experience in a dietary supplement environment.
    • Skilled in the use of Microsoft office software to include Word, Excel, PowerPoint, and Outlook.
    • Strong interpersonal skills, detail oriented and able to coordinate/manage multiple tasks simultaneously.
    • Capable of accomplishing workload and additional projects with minimal supervision.
    • Ability to communicate effectively (in person, phone, email), cross reference information and excel within a team environment.
    • No dietary restrictions or allergies.
    • Must be a non-tobacco user and will not use tobacco products on or off the job during the tenure of employment in Quality Assurance, as it may affect taste accuracy testing.

    Preferred Qualifications

    • 6 years Quality Assurance experience in a dietary supplement environment.
    • Experience with Quality Management Software, such as Master Control.

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