Covance

  • Senior Quality Assurance Auditor

    Job Location(s) US-NJ-Princeton | US-PA-King of Prussia | US-TX-Dallas | US-IL-Chicago | US-CA-San Francisco | US-NC-Raleigh-Durham
    Job Number
    2018-24413
    Job Category
    Quality Assurance
    Position Type
    Full-Time
  • Job Overview

    The Senior Quality Assurance Auditor can be remotely located anywhere in the United States.

     

     

    Essential Job Duties:

    • Lead audit teams in the conduct, reporting and follow up of regional and global QA audits, ensuring compliance to applicable SOPs, Master Audit Plan, and within specified timeframes and quality standards
    • Leads complex audits (e.g., directed, process, systems, office)
    • Provide suitable recommendations for audit observations; ensures auditors deliver appropriate CAPAs and follows them up through closure. Escalates, as appropriate, where resolution of audit findings is inadequate
    • Proactively identifies and leads process improvement activities / SOP creation and revisions
    • Able to host client audits and able to support regulatory inspections
    • Leads and/or participates in special projects
    • Represents Audit QA on project teams and other internal forums
    • Trains and mentors junior QA Audit staff/ support on-boarding of new personnel

    Education/Qualifications

    Required:

    • University/college degree BA/BS (life science preferred),or equivalent
    • Thorough knowledge, understanding and experience applying ICH Guidelines, GCPs including applicable regulatory requirements for the conduct of clinical development programs
    • Knowledge of the drug development process from the perspective of a contract research organization

      Competencies:

        Required:

    • Excellent written and oral presentation skills
    • Excellent organization and planning skills and attention to detail
    • Proven interpersonal skills
    • Demonstrated ability to handle multiple competing priorities across clinical operating unit
    • Ability to function as a member of a global clinical team

    Desired:

    • Core and Leadership Competencies: Focus on clients, Works well with others, Develops self and team, and Gets it done

     Working Conditions:

    • Remotely (home-based), traveling to other Covance offices, sponsor premises, investigator sites, pharmacies, third party vendors when required

    Experience

    Experience: Minimum Required:

    • 5 years CRO/Pharmaceutical experience
    • 4 years in a GXP quality role, including at least 2 years in a GCP quality audit role required

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