Dohmen Life Science Services

  • Internal Auditor Analyst

    Job Locations US-TN-Memphis
    Job ID
    2017-1900
    # of Openings
    1
    Category
    Quality Assurance & Regulatory Compliance
  • Overview

    OUR COMPANY

    Since 1858, Dohmen has been driven by the desire to get safe and effective treatments and cures to the people that need them most. As entrepreneurs, we’ve looked for new and better ways of doing this year after year. Today, as Dohmen Life Science Services, we bring the industry’s most comprehensive service array to Medical Device, Biotech and Pharmaceutical entrepreneurs, helping them get farther faster and keeping them focused on innovations that improve lives.

     

    Our behavior is guided by four simple values –

    Caring: We are empathetic and respectful.  We ask “How can I help you?”

    Committed: We are dedicated and persistent.  We ask “How can I make it happen?”

    Creative: We are inventive and imaginative. We ask “How can I do it better?”

    Collaborative: We are cooperative and share our knowledge. We ask “How can we achieve success?”

    Courageous: We’re willing to risk failure over inaction. We ask “how can I challenge myself”

    This perspective defines us. How we act, how we do business, how we work with our clients and how we work with each other. They are the essence of what makes us successful. They are what set us apart.

     

     

    THE POSITION:

    This position is responsible for the planning, execution and management of internal and external audits.    In addition, responsible for overall management of facility environmental monitoring and control systems. Accountable for following up on audit results and actions associated with environmental elements, ensuring proper associated records are maintained. Also responsible for conducting external supplier and vendor audits and facilitating the vendor qualification process.

     

     

    POSITION SUCCESS FACTORS:

    • deTAILED ORIENTED
    • gOOD RECORD-KEEPING SKILLS
    • fACT-FINDING ABILITIES
    • Strong organizational skills

     

     

    ESSENTIAL FUNCTIONS:

    • Independently performs all phases of audit work including planning, fieldwork, and reporting.
    • Manages and has direct oversight of environmental facility condition and status.
    • Understands and clearly documents business processes in order to develop audit and environmental control objectives.
    • Determines and clearly documents any risks identified from audits and environmental results.
    • Obtains facts and other concrete evidence to support conclusions.
    • Clearly and thoroughly documents work with a well-organized set of work papers.
    • Ensures resolutions are tracked, for assessment of timely completion.
    • Performs effective checks on corrective actions.
    • Manages projects as assigned
    • Maintain all associated records
    • Coordinates internal audit program; serve as a support auditor for other internal audit programs.
    • Facilitate Process improvements efforts associated with audit resolutions and other elements.

    Responsibilities

    Responsibilities:

    • Conducts Internal Audits
    • Conducts External Audits
    • Facilitates the vendor qualification program
    • Manages environmental processes; thermal mapping, corrective actions and follow up
    • Documents results, with good record keeping systems
    • Determine effectiveness of resolutions
    • Support ongoing quality system programs.
    • Support quality assurance and regulatory activities
    • Other duties as assigned.

    Qualifications

    MINIMUM KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:

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

    • Experience in quality auditing in a quality or regulatory department
    • Experience with environmental monitoring and control; facility
    • Ability to make assessment sand draw conclusions from supporting evidence
    • College degree – minimum Associates Degree.
    • Some travel involved.

     

     

    Personal Skills/Attributes/Qualifications

    • Good communication skills
    • Analytical abilities
    • Strong follow up attribute.

     

    Working conditions

    To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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