Quality Assurance Compliance Auditor – Bioanalysis

<h2>Job Overview:</h2><p style="margin-bottom: 6.75pt;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: #333333;">Are you an experienced GLP/GCP auditor? Would you like to apply your large molecule bioanalysis scientific expertise to Quality Assurance? If so, w</span><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: black;">e want you to join our Global QA team as the </span><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: #333333;">Quality Assurance Compliance Auditor – Bioanalysis</span><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: black;"> in Indianapolis, IN. </span></p><p style="margin-bottom: 6.75pt;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: black;">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.</span></p><p style="margin-bottom: 6.75pt;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: #333333;">Position Overview</span></p><ul><li style="margin-bottom: .0001pt;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif;">Development and delivery of training (to operational groups)</span></li><li style="margin-bottom: .0001pt;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif;">Delivery of training in performance of audits (basic, intermediate audit activities)</span></li><li style="margin-bottom: .0001pt;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif;">Provide advice and guidance on aspects of quality and compliance</span></li><li style="margin-bottom: .0001pt;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif;">Provide consultation to the operational team on quality issues</span></li><li style="margin-bottom: .0001pt;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif;">Cross-site QA and operational relationship, provide recommendations for improving compliance and/or efficiency</span></li><li style="margin-bottom: .0001pt;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif;">Work with operational management to support Quality topics and/or working on projects with QA team on other sites [showing development of collaboration skills]</span></li><li style="margin-bottom: .0001pt;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif;">Manage local Quality initiatives aimed at improving compliance and/or efficiency of the local QA organization</span></li><li style="margin-bottom: .0001pt;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif;">Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed</span></li><li style="margin-bottom: .0001pt;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: #333333;">Consideration would be given to a scientist with commensurate experience</span></li></ul><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: #333333;"><span style="font-size: 8pt; font-family: Arial, sans-serif; color: #000000;">#LI-DZ1</span></span></p><h2>Education/Qualifications:</h2><ul><li><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif;">A minimum of a Bachelor’s Degree in Life Sciences preferred (or equivalent Life Science experience)</span></li><li><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif;">Experience may be substituted for education</span></li></ul><h2>Experience:</h2><ul><li><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif;">4 years’ in a regulatory environment (experience in GLP/GCP roles)</span></li><li><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: #333333;">Working knowledge of the FDA Guidance for Industry Bioanalytical Method Validation, experience with auditing/reviewing large molecule bioanalysis, including PK and Antidrug Antibody</span></li><li><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: #333333;">Experience with Watson LIMs, SoftMax Pro, MSD and LC/MS is desired</span></li><li><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif;">Experienced GLP/GCP auditor</span></li><li><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: #333333;">Laboratory experience will be considered</span></li><li><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif;">Able to influence QA strategy</span></li><li><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif;">Ability to communicate to groups</span></li><li><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif;">Knowledge of multiple operational areas</span></li><li><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif;">Knowledge of industry quality systems/standards and ability to apply appropriate regulatory knowledge to multiple scenarios</span></li></ul>