Senior QA Compliance Auditor

Company: LabCorp
Location: Greenfield
Posted on: March 18, 2023

Job Description:

Take your career to the next level as a Senior QA Compliance Auditor on our Global Quality Compliance Team with Labcorp Drug Development in Greenfield, IN.Labcorp Drug Development's work in developing new pharmaceutical solutions has an incredible impact on millions of lives worldwide. Be a part of this life-saving work and help improve patients' lives while growing your career.
This role:

• 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 followedMinimum Required:
  • 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 scenariosEducation/Qualifications:Recommended: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,
      • Experience may be substituted for education.Join us and discover why Labcorp Drug Development has been named by:
        • Fortune-- Magazine as one of the World's Most Admired Companies 2022 for the fourth consecutive year
        • Forbes as one of the World's Best Employers 2022 and more than 90% of the top 20 global pharmaceutical companies are repeat customersLabcorp is proud to be an Equal Opportunity Employer:
          As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
          For more information about how we collect and store your personal data, please see our--.--

Keywords: LabCorp, Indianapolis , Senior QA Compliance Auditor, Accounting, Auditing , Greenfield, Indiana