• Quality Systems Specialist I

    Job Locations US-WI-Madison
    Req No.
    2018-2540
    Category
    Quality Assurance & Regulatory Affairs
    Type
    Regular Full-Time
  • Summary of Major Responsibilities

    The Quality Systems Specialist I supports the Quality Systems team with administration of Exact Sciences’ Quality Management Systems. Primary responsibilities include assessment and administration of quality document and data projects, including assurance of proper document and record control in accordance with Good Manufacturing Practices.

    Essential Duties and Responsibilities

    • Perform document control processes in the electronic quality management system (EQMS) for approval and release of Quality System documents
    • Maintain and improve processes to monitor document workflow performance, compliance and reliability.
    • Generate, prepare and issue data for assigned quality reports.
    • Assist with the Records Management program, including the following:
      • Scan completed records to create a PDF image, verify, and input to EQMS for storage and retrieval.
      • File paper record onsite or process for offsite storage.
    • Assist with the development of document templates for various document types.
    • Perform general word processing for various procedures and other document types.
    • Assist with developing, maintaining, and following document style mechanic guides for consistency in document writing.
    • Assist with training Program Administration including the following:
      • Entry of training Record data into the appropriate system.
      • Ensure individual training compliance utilizing reporting functions.
    • Assist with other documentation/record/data support duties as assigned.

    Qualifications

    Mandatory Skills

    • Advanced knowledge and practical skills in utilizing MS Word, Excel, and Visio.
    • Ability to interface and work effectively with all levels of the organization and to work independently with moderate supervision.
    • Excellent oral and written communication skills, with strong attention to detail and record keeping skills.
    • Computer skills including working with Windows and/or similar operating systems.

     Preferred Qualifications

    • 1 or more years’ relevant work experience, preferably in a GMP and/or ISO environment.
    • Experience with EQMS systems and applications (Agile PLM).

     

    Education and Experience

    • Bachelor’s degree in a science or technical field, or related field with the equivalent combination of education and experience.

     

    Physical Requirements

    • Ability to use computers daily in an interactive manner for extended periods of time.
    • Ability to sit for an extended period of time.
    • Ability to frequently and accurately communicate with employees in person, via the telephone or by email.
    • Ability to stand for extended periods of time and up to 3 hours at a time.

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    Exact Sciences is an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company’s affirmative action program is available to any applicant or employee for inspection upon request.

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