Sr QA Compliance Auditor (GCP)

Job Overview:Labcorp Drug Development is seeking candidates for a Senior QA Compliance Auditor. The Senior QA Compliance Auditor will be remotely (home-based) located anywhere within the United States.Conduct work as identified on the audit activity table (listing on table is not all inclusive but a representative sample).Contributes to global QA policies on interpretation/ application of regulations.Provide subject matter expertise to projects Support team in CAPA plan creation.Hosts external audits/inspections e.g. regulatory inspections, strategic clients. Assists with the facilitation of audit responses.Supports the QA-to-QA relationship with key client(s).Delivery of training in performance of audits (basic, intermediate, complex).Participate (for multi-regulatory topics in area of expertise) global Quality initiative(s) aimed at improving compliance and/or efficiency of the QA organization.Supports the reporting of quality metrics and implementation of necessary corrective actions and/or process improvements via appropriate forum (e.g. Monthly Reports, Site Quality Review, Liaison meetings).Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed.Other duties as assigned by management.Travel up to 50% with respect to any pandemic-related restrictions.Education/Qualifications:A minimum of a Bachelor''s 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:6 years in regulatory environmentMust have experience in GCP roles.Experience of industry quality systems/standards.Excellent interpersonal/organizational skills, e.g. communication, decision making, negotiating, problem solving.Able to influence QA strategy systems/standards and ability to apply appropriate regulatory knowledge to multiple scenarios.Preferred: Phase II to IV experienceInvestigator site audit experienceLI-REMOTE

Created: 2021-11-29