OMNI Human Resource Management

  • Quality Assurance Auditor

    Job ID
    2018-2136
    Client
    Vince & Associates Clinical Research
    Job Location(s)
    US-KS-Overland Park
  • Overview

    Altasciences- Vince and Asso

    Do you want a fast-paced, exciting and innovative career in research? Vince and Associates Clinical Research is currently looking for a Quality Assurance Auditor for their Overland Park, KS campus.

    Altasciences Clinical Research, encompassing Algorithme Pharma, Vince and Associates Clinical Research and Algorithme Pharma USA, is one of the largest early phase clinical research organizations (CROs) in North America. As a leading, full-service CRO, we have extensive expertise in the execution of a wide range of Phase I/II clinical studies, especially complex trials in healthy normal volunteers and patient populations.

    The Quality Assurance Auditor carries out systematic and independent examination (i.e., audits) of multiple trial-related activities and documents, to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, standard operating procedures (SOPs), GxPs and the applicable regulatory requirements.

     

    Responsibilities

    • Write QA audit reports and submit for final approval to the QA Manager- convey/present to the audited department’s management
    • Audit all disciplines (examples of disciplines include Screening, Recruiting, and Clinical Operations
    • Write and issue inspection reports while working with internal customers to ensure that inspection findings are clearly communicated and understood
    • Evaluate inspecting-finding responses to ensure they are written to address the findings appropriately
    • Ensure through phase and data inspections that the SOPs, which are involved in the conduct of a study, are current and practiced
    • Identify and communicate opportunities for process improvement based on audit and inspection observations
    • Participate in and guide process improvement activities in both small intradepartmental groups as well as complex and possible multi-departmental interactions
    • Maintain necessary documentation of QA records and study files
    • Notify management of observed quality and compliance trends in the areas inspected
    • Recommend modification in procedures to fit special needs or problems and involves manager when assistance in process improvement/resolution is necessary
    • Interprets GxPs and associated regulatory documents to facilitate auditing and process improvement recommendations
    • Carry out appropriate self-development efforts as directed

     

    Qualifications

    •  Bachelor’s Degree in the life science related field or equivalent experience
    • 4-Year Degree or substantial experience in a QA role within a Phase I CRO
    • 5 years Clinical Research experience, preferably with prior QA experience
    • Experience in dealing with regulatory agencies and sponsors
    • Ability to interface, interact and present multiple levels of employees with the organization
    • Demonstrated problem solving and time management skills

    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, and protected veteran status, or disability status.

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