EVERSANA

  • Quality Associate

    Job Locations US-OH-Mason
    Job ID
    2019-4491
    # of Openings
    1
    Category
    Legal
  • Overview

    OUR CULTURAL BELIEFS

    Patient Minded I act with the patient’s best interest in mind.

    Client Delight I own every client experience and its impact on results.

    Take Action I am empowered and empower others to act now.

    Grow Talent I own my development and invest in the development of others. 

    Win Together I passionately connect with anyone, anywhere, anytime to achieve results.

    Communication Matters I speak up to create transparent, thoughtful and timely dialogue.

    Own It I hold myself and others accountable for results.

    THE POSITION:

    The most important aspect of this role is to provide quality assurance support to Operations through the maintenance of the Quality Management System (QMS) and associated activities including system documentation, training and supporting the internal audit effort to ensure compliance.  This position is responsible for the official record-keeping of QMS documentation from document creation to obsolescence.

     

    Responsibilities

    ESSENTIAL DUTIES AND RESPONSIBILITIES:
    Our employees are tasked with delivering excellent business results through the efforts of their teams.  These results are achieved by:

    • Maintain the documentation system; implementing controlled documents; tracking, managing and storing documents; all to ensure effective communication of requirements
    • Review user documentation updates to ensure that the content is accurate for approval and release to ensure effective communication of requirements
    • Maintain updated and accurate client-specific documentation
    • Evaluate existing procedures and quality practices, and when necessary, make recommendations to senior management and client designates for documentation changes
    • All other duties as assigned

    Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

    EXPECTATIONS OF THE JOB:

    • Official record-keeping of documentation from creation to obsolescence to ensure effective communication of requirements
    • Work with client representatives to obtain approvals of client-specific documentation
    • Assist in achieving and maintaining satisfactory results in client and regulatory audits to support compliance and client delight
    • Act as the Document Control Coordinator representative for the Quality Assurance team.
    • Work with Subject Matter Experts on procedure development and establish, follow and improve corporate and site procedures and associated instructions and resource documents
    • Support the site internal audit program through the planning, performance and documentation of internal quality, process-based audits, and assist in the closure of audit findings.
    • New team member orientation and onboarding, as needed
    • Travel (less than 20%)
    • Hours (40 hours per week, Monday through Friday)

    The above list reflects the general details necessary to describe the expectations of the position and shall not be construed as the only expectations that may be assigned for the position.

     

    An individual in this position must be able to successfully perform the expectations listed above.

    Qualifications

    MINIMUM KNOWLEDGE, SKILLS AND ABILITIES:

    The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required.

    • Education:  Associate’s degree in health sciences, biological science or other life sciences
    • Experience and/or Training:  Two (2) years prior work experience in a quality, healthcare or life sciences roles, and two (2) years of experience in a documentation control role
    • Technology/Equipment:  Strong skills in MS Office programs, i.e., Excel, Word and PowerPoint
    • Meticulous attention to detail and a demonstrated willingness to complete routine administrative tasks
    • Ability to work in a team environment
    • Excellent written and verbal communication skills, including proficiency in writing and editing skills with acute attention to quality and style 

    PREFERRED QUALIFICATIONS:

    • Education:  Bachelor’s degree in health sciences, biological science or other life sciences
    • Experience and/or Training:  Knowledge of cGMP and Specialty Pharmacy
    • Licenses/Certificates:  Ability and willingness to obtain industry certifications (ASQ Certified Quality Improvement Associate, Six-Sigma Yellow Belt, etc.)
    • Technology/Equipment:  Advanced skills in MS Office programs, i.e., Excel, Word and PowerPoint

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