Dohmen Life Science Services

  • Quality Associate

    Job Locations US-MO-Chesterfield
    Job ID
    2018-2054
    # of Openings
    1
    Category
    Quality Assurance & Regulatory Compliance
  • Overview

    OUR CULTURE:

    At Dohmen Life Science Services, we are committed to keeping our clients for life, ensuring no conflict of interest exists, achieving continuous innovation, and focusing on continuous improvement.  Our behavior is guided by five simple values that define how we work and are the essence of what makes us successful:

     

    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?”

     

    THE POSITION:

    The most important aspect of this position 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.

     

    Critical RESPONSIBILITIES:

    • Maintain the documentation system; implementing controlled documents; tracking, managing and storing documents created and modified by different users
    • Review user updates to ensure that the content is accurate for approval and release of documentation
    • 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

     

    essential duties and responsibilites:

    • Official record-keeping of documentation from creation to obsolescence
    • Work with client representatives to obtain approvals of client-specific documentation
    • Assist in achieving & maintaining third party accreditations, such as VAWD, URAC, ACHC, etc., and satisfactory results in client and regulatory audits
    • Support the administration of pre-commercial clinical trials according to good clinical practices and standard operating procedures
    • Act as the Document Control Coordinator representative for the Quality Department.
    • Monitoring and reporting on the status of Periodic Document Reviews (PDRs)
    • Assist with the creation and development of documents for Change Control and maintain Change Control documentation in the Intelex system
    • Support Learning & Development to ensure regulatory compliance of training requirements
    • Support the Information Retention Policy (IRP) coordinator to ensure compliance to record retention requirements through the coordination of related activities
    • Work with Subject Matter Experts on procedure development and establish, follow and improve corporate and site procedures and associated instructions and resource documents
    • Perform internal quality audits as a member of the Internal Audit team
    • Participation in process improvement activities
    • Some travel may be required (less than 20%)
    • Other duties as assigned

     

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

     

    An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

     

    MINIMUM qualifications:

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

     

    • Associate’s degree in health sciences, biological science, or other life sciences
    • Two (2) years prior work experience in a Quality, healthcare or life sciences role, and two (2) years of experience in a documentation control role
    • 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:

     

    • Bachelor’s degree in health sciences, biological science, or other life sciences
    • Knowledge of cGMP and specialty pharmacy
    • Ability and willingness to obtain industry certifications (ASQ Certified Quality Improvement Associate, Six-Sigma Yellow Belt, etc.)
    • Advanced skills in MS Office programs i.e. EXCEL, WORD and PowerPoint

      

    Physical AND Mental Demands:

    This is a largely sedentary role.  While performing the duties of this job, the employee is regularly required to talk, hear, type and engage in repetitive motion. 

     

    The employee frequently is required to walk; use hands to finger, handle or feel; and reach with hands and arms.  The employee is occasionally required to stand or grasp. The employee is intermittently required to stoop or crouch; push or pull; or kneel. 

     

    The employee must occasionally lift and/or move up to 10 pounds and intermittently lift and/or move up to 25 pounds.  Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

     

    This role requires mental alertness. The employee must regularly communicate both verbally and written; concentrate on tasks; and remember and observe details. The employee must frequently adjust to changes; handle stress and emotions; and think analytically.

     

    The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

     

    Working Environment:

    This job operates in a professional office environment. This role routinely uses standard office equipment. The noise level in the work environment is usually moderate.  The employee is not substantially exposed to environmental conditions.

     

    The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

     

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