• Quality Assurance Specialist

    Posting Date 3 months ago(1/31/2018 2:34 PM)
    Requisition ID
    Job Location(s)
    Bloomington IN United States
    Less than 10%
    Shift Type
    Position Type
    Full Time
    Cook Regentec LLC
  • Overview

    Work under the Cook Biodevice Quality Management System (QMS). Responsibilities include process maintenance, and performance of, investigation management (CAPA, Deviations, and Complaints), Document & Change Control, risk management, Quality Management Review, internal and external audits, review of design and development related documentation etc.


    • Performs procedures as required under the QMS
    • Maintain Document Control processes to ensure that documents (e.g., policies, SOPs, forms, templates) are controlled and managed to support the Quality Management System.
    • Ensure that records used to demonstrate compliance are controlled and available for audits.
    • Assist authors with the creation and revision of documents through completion of document change requests.
    • Support Change Control system management.
    • Support record retention management.
    • Maintain CAPA system processes.
    • Support Feedback and Complaint system management, ensuring timely process completion.
    • Complete, participate, review and approve investigations related to CAPA, Deviations, Feedback, and Complaints as necessary.
    • Review documents for approval as directed. These may include audit reports, supplier qualifications, reports, QMS documents, and manufacturing batch records. This list is not all inclusive.

    • Write or update procedures under the responsibility of QA.
    • Monitor, track, and evaluate Quality System process data.
    • Facilitate the Quality Management Review meetings, including compiling process data for reporting.
    • Complete, participate, review and approve change control as needed.
    • Apply the understanding of the Quality Policy Manual in carrying out job responsibilities.
    • Complete records accurately for the duties trained.
    • Assist with internal audits of the quality system to determine the effectiveness and dependability of the system
    • Assist in internal and external assessments including writing assessment reports as needed.
    • Maintain current knowledge of FDA, ISO and industry requirements.
    • Responsible for reporting quality issues to the QA Manager.
    • May include other duties as defined by the department Manager.


    • Bachelor’s degree required
    • Experience working in GMP environment preferred
    • At least 1+ years’ experience working in a Quality Assurance or Quality Engineering-related function within a regulated industry, such as pharma, medical device, or biologics required
    • Excellent and effective English written and oral communication skills

    • Experience working with document management/control systems.
    • Knowledge in current Good Documentation Practices preferred


    Physical Requirements:

    • General office environment
    • Must be able to sit for long periods of time
    • Less than 10% travel

    • Position requires flexibility to work at Indianapolis and Bloomington locations


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