• Quality Assurance Specialist (20-0067)

    Job Description

    Streck is recruiting for a Quality Assurance Specialist to join our Quality Assurance area. This position will be responsible for quality activities performed in their assigned department(s), ensuring compliance with regulatory requirements and internal procedures. Under general supervision, this position provides day-to-day quality support to the designated departments.

    The primary responsibilities include:

    • Assures that any observations/deviations are properly investigated and explained.
    • Provides guidance with Nonconforming process.
    • Provides support for the CAPA process to include CAPA investigation and closure.
    • Maintains awareness of activities by routine direct observation of processes. Interacts frequently with Operations staff to provide quality perspective on routine operations and support system. Addresses conditions/practices with appropriate personnel, documents and reports finding to Management.
    • Maintains Quality System reporting tools, such as error tracking spreadsheets and other documents as requested by management.
    • Performs batch/lot file reviews for compliance with appropriate SOPs 

    Requirements include:

    • Bachelor’s degree in biology, chemistry or related discipline preferred. Demonstrated experience in an FDA or USDA production environment may substitute for technical education.
    • Minimum of one to four years of related work experience in an FDA regulated manufacturing environment.
    Contact Information
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