Covance

  • Sr Auditor QA&C

    Job Location(s) US-Nationwide | CA-BC-Vancouver
    Job Number
    2018-20680
    Job Category
    Quality Assurance
    Position Type
    Full-Time
  • Job Overview

    Sr. QA Auditor (GCP Auditor)  

    (home or office based position)

    Leads audit teams in the conduct, reporting and follow up of regional and local QA audits, ensuring compliance to applicable SOPs, Master Audit Plan, and within specified timeframes and quality standards

    • Conducts complex, directed, and/or time sensitive QA audits
    • Participates in global QA audits
    • Provides suitable recommendations for audit observations; ensures auditees deliver appropriate CAPAs and follows them up through closure. Escalates, as appropriate, where resolution of audit findings is inadequate
    • Leads process improvement activities / SOP updates
    • Able to support client audits and regulatory inspections
    • Leads and/or participates in special projects
    • Represents Audit QA on project teams and other internal forums
    • Trains and mentors junior staff
    • 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
    • Core and Leadership Competencies: Focus on clients, Works well with others, Develops self and team, and Gets it done

    Education/Qualifications

     

    • University/college degree BA/BS (life science preferred)
    • 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
    • Spanish fluency perferred but not required

    Experience

     

    • 4 years CRO/Pharmaceutical experience
    • 3 years in a GXP quality role, including at least 1 year in a GCP quality role required

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