This job posting may have expired!
Use our `search` to find similar offers.
Similar jobs

Senior QA Compliance Auditor

Laboratory Corporation of America Holdings (Covance)

Durham, North Carolina, United States

<h2>Job Overview:</h2><p style="margin: 0px;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">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.</span></p><ul><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Conduct work as identified on the audit activity table (listing on table is not all inclusive but a representative sample).</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Contributes to global QA policies on interpretation/ application of regulations.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Provide subject matter expertise to projects Support team in CAPA plan creation.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Hosts external audits/inspections e.g. regulatory inspections, strategic clients. Assists with the facilitation of audit responses.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Supports the QA–to-QA relationship with key client(s).</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Delivery of training in performance of audits (basic, intermediate, complex).</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Participate (for multi-regulatory topics in area of expertise) global Quality initiative(s) aimed at improving compliance and/or efficiency of the QA organization.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">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).</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Other duties as assigned by management.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Travel up to 50% with respect to any pandemic-related restrictions.</span></li></ul><h2>Education/Qualifications:</h2><ul><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">A minimum of a Bachelor’s Degree in a Pharmacy, Chemistry or Biology related discipline.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Postgraduate degree (MSC or equivalent) in science or management related discipline, preferable.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Experience may be substituted for education.</span></li></ul><h2>Experience:</h2><ul><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">6 years in regulatory environment (experience in GCP roles).</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Experience of industry quality systems/standards.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Excellent interpersonal/organizational skills, e.g. communication, decision making, negotiating, problem solving.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Able to influence QA strategy systems/standards and ability to apply appropriate regulatory knowledge to multiple scenarios.</span></li></ul><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Preferred:</span><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"> </span></p><ul><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Phase II to IV experience</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Investigator site audit experience</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">GCP QA experience </span></li></ul><p style="margin: 0px;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">#LI-REMOTE</span></p>

Job posted: 2021-07-06

3