QA Auditor IV - GLP/GCP/GMP

<h2>Job Overview:</h2><p style="margin-bottom: 6.75pt;"><span style="font-size: 12.0pt; font-family: 'Arial',sans-serif; color: #333333;">QA Auditor IV - GLP/GCP/GMP Early Drug Safety Assessment</span></p><p style="margin-bottom: 6.75pt;"><span style="font-size: 12.0pt; font-family: 'Arial',sans-serif; color: #333333;">Do you have GLP/GCP/GMP auditing experience? If so, w</span><span style="font-size: 12.0pt; font-family: 'Arial',sans-serif; color: black;">e want you to join our Global QA team as a QA Auditor IV in Greenfield, IN.</span></p><p style="margin-bottom: 6.75pt;"><span style="font-size: 12.0pt; font-family: 'Arial',sans-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;"><strong><span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;">We are offering a sign-on bonus of $4,000 ($2,000 upon hire and another $2,000 after 6 months; external candidates only)</span></strong></p><p style="margin-bottom: 6.75pt;"><span style="font-size: 12.0pt; font-family: 'Arial',sans-serif; color: #333333;">Position Overview</span></p><ul><li><span style="font-size: 12.0pt; font-family: 'Arial',sans-serif; color: black;">Evaluates responses to inspection reports and performs follow-up with respondents, management, or others, if needed, to ensure resolution</span></li><li><span style="font-size: 12.0pt; font-family: 'Arial',sans-serif; color: black;">Report on relevant quality metrics (for multiple topics/departments) and highlight trends</span></li><li><span style="font-size: 12.0pt; font-family: 'Arial',sans-serif; color: black;">Provide consultation to the operational team (e.g. as they revise/write controlled documents)</span></li><li><span style="font-size: 12.0pt; font-family: 'Arial',sans-serif; color: black;">Delivery of training in performance of audits (basic, intermediate audit activities)</span></li><li><span style="font-size: 12.0pt; font-family: 'Arial',sans-serif; color: black;">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><span style="font-size: 12.0pt; font-family: 'Arial',sans-serif; color: black;">Contribute to local Quality initiatives and process improvement initiatives aimed at improving compliance and/or efficiency of the local QA organization</span></li><li><span style="font-size: 12.0pt; font-family: 'Arial',sans-serif; color: black;">Create and/or re-write QA SOPs based on findings from local quality initiatives. </span></li><li><span style="font-size: 12.0pt; font-family: 'Arial',sans-serif; color: black;">Organizing, Prioritizing and Managing all aspects of workload to meet business needs.</span></li><li><span style="font-size: 12.0pt; font-family: 'Arial',sans-serif; color: black;">Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed</span></li></ul><p style="margin: 0px;"><span style="font-size: 12.0pt; font-family: 'Arial',sans-serif; color: black;"><span style="font-size: 8pt; font-family: arial, helvetica, sans-serif;">#LI-DZ1</span></span></p><h2>Education/Qualifications:</h2><ul><li><span style="font-size: 12.0pt; font-family: 'Arial',sans-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: 'Arial',sans-serif;">Experience may be substituted for education</span></li></ul><h2>Experience:</h2><ul><li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">3 years’ in regulatory environment (GXP; experience in GLP/GCP roles preferred)</span></li><li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Knowledge of industry quality systems/standards and able to apply (applicable) regulations in order to monitor compliance </span></li><li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Experienced GXP auditor</span></li><li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Experienced in process improvement </span></li><li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Clear communication skills, including ability to provide clear feedback </span></li><li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Able to clearly articulate processes in order to provide training</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Able to influence process improvement initiatives / offer solutions</span></li></ul>