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QA Compliance Lead Auditor

Company: Labcorp
Location: Durham
Posted on: November 19, 2021

Job Description:

Job Description: Job Overview: Conduct work as identified on the audit activity table related to CDCS (listing on table is not all inclusive but arepresentative sample) Takes lead in generation of global QA policies on interpretation/ application of regulations Provide subject matter expertise and leads/influences the ED/CS/CDS/CLS organization byproviding guidance and client/authority facing support on specific niche regulatory topics Hosts (i.e. for cause inspection, non-standard authority inspections, country-specific or scopeof inspection) external audits/inspections e.g. regulatory inspections, strategic clients. Facilities and reviews responses to the audit. Leads the reporting of quality metrics and implementation of necessary corrective actionsand/or process improvements via appropriate forum (e.g. Monthly Reports, Site QualityReview, Liaison meetings). Manage (for own area of expertise) / participate (for multi-regulatory topics) in broad scopeglobal Quality initiative(s) aimed at improving compliance and/or efficiency of the QAorganization Acts as a backup for QA Manager; provides monthly report of activities to QA Manager;performs other related duties as assigned Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicatedin applicable controlled documents, are followed Other duties as assigned by management.Education/Qualifications: A minimum of a Bachelors Degree in a Pharmacy, Chemistry or Biology related discipline Postgraduate degree (MSC or equivalent) in science or management related discipline,preferable Experience may be substituted for education.Experience: 8 years in regulatory environment (experience in GCP roles) Regulatory expertise - detailed knowledge of specific regulation/ multiple regulations Experienced Lead Auditor Strategic communication with clients Experience leading process improvement initiatives

Keywords: Labcorp, Durham , QA Compliance Lead Auditor, Accounting, Auditing , Durham, North Carolina

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