Senior Auditor II, Audit & Inspection Management
Company: Covance
Location: Durham
Posted on: January 8, 2021
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Job Description:
Job Overview:Covance is seeking candidates for a Senior Auditor
II, Audit & Inspection--Management. The Senior Auditor II, Audit &
Inspection Management can be home based anywhere within the United
States or office based in Durham, NC. The Senior Auditor II, Audit
& Inspection Management is responsible for leading internal,
external, regional and global QA audits per Standard Operating
Procedures and Master Audit Plan, assuring that audited systems,
processes and their outcomes comply with applicable international
and national regulations and guidelines, and fulfill client and
Covance requirements. The position assures that audits assigned are
completed on time and within budget, including audit reporting and
CAPA follow up and closure.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 auditees 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* Travel up to 50% with respect to any
pandemic-related restrictionsEducation/Qualifications:*
University/college degree BA/BS (life science preferred), or
equivalentThorough 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 organizationExperience:* 5 years
CRO/Pharmaceutical experience* 4 years in a GxP quality role,
including at least 2 years in GCP quality auditing role.* GCP
auditing experience for clinical research Phase II/III; auditing
oncology studies desirable.#LI-REMOTE
Keywords: Covance, Durham , Senior Auditor II, Audit & Inspection Management, Accounting, Auditing , Durham, North Carolina
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