Covance Senior Auditor Quality Assurance & Compliance in Boston, Massachusetts

Job Overview

The Senior Auditor Quality Assurance & Compliance position can be remotely located anywhere within the United States.

  • 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

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

Experience

  • 4 years CRO/Pharmaceutical experience

  • 3 years in a GXP quality role, including at least 1 year in a GCP quality role required

Job Number 2019-27003

Job Category Quality Assurance

Position Type Full-Time

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