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Quality Assurance Compliance Auditor – Bioanalysis

Company: Labcorp
Location: Indianapolis
Posted on: July 21, 2021

Job Description:

Job Overview:

Are you an experienced GLP/GCP auditor? Would you like to apply your large molecule bioanalysis scientific expertise to Quality Assurance? If so, we want you to join our Global QA team as the Quality Assurance Compliance Auditor – Bioanalysis in Indianapolis, 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.

Position Overview

  • Development and delivery of training (to operational groups)
  • Delivery of training in performance of audits (basic, intermediate audit activities)
  • Provide advice and guidance on aspects of quality and compliance
  • Provide consultation to the operational team on quality issues
  • Cross-site QA and operational relationship, provide recommendations for improving compliance and/or efficiency
  • Work with operational management to support Quality topics and/or working on projects with QA team on other sites [showing development of collaboration skills]
  • Manage local Quality initiatives aimed at improving compliance and/or efficiency of the local QA organization
  • Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed
  • Consideration would be given to a scientist with commensurate experience

 

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Education/Qualifications:

  • A minimum of a Bachelor’s Degree in Life Sciences preferred (or equivalent Life Science experience)
  • Experience may be substituted for education

Experience:

  • 4 years’ in a regulatory environment (experience in GLP/GCP roles)
  • Working knowledge of the FDA Guidance for Industry Bioanalytical Method Validation, experience with auditing/reviewing large molecule bioanalysis, including PK and Antidrug Antibody
  • Experience with Watson LIMs, SoftMax Pro, MSD and LC/MS is desired
  • Experienced GLP/GCP auditor
  • Laboratory experience will be considered
  • Able to influence QA strategy
  • Ability to communicate to groups
  • Knowledge of multiple operational areas
  • Knowledge of industry quality systems/standards and ability to apply appropriate regulatory knowledge to multiple scenarios

Keywords: Labcorp, Indianapolis , Quality Assurance Compliance Auditor – Bioanalysis, Other , Indianapolis, Indiana

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