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Labcorp Sr QA Compliance Auditor (GCP) in Topeka, Kansas

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 environment

  • Must 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 experience

  • Investigator site audit experience

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