Covance by Labcorp Job - 39269418 | CareerArc
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Company: Covance by Labcorp
Location: King of Prussia, PA
Career Level: Mid-Senior Level
Industries: Healthcare, Pharmaceutical, Biotech

Description

Job Overview:

Covance by Labcorp 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 (experience in GXP 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
  • GCP QA experience 

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