Quality Auditor - GLP/GCP

Labcorp•Indianapolis, IN

2d•Onsite

About The Position

Labcorp is a global leader in laboratory services, providing the insights and answers that help healthcare providers, patients, researchers, pharmaceutical companies and health systems make confident decisions and improve outcomes. Through our unparalleled science, data, technology and laboratory network, we advance diagnostics, accelerate innovation and help address some of the world’s most important health challenges. As we shape the future of healthcare, we are leveraging advanced technologies, intelligent digital solutions and data-driven innovation across our operations to enhance how work gets done and deliver greater value to customers and patients. With our global scale and deep expertise, you’ll have the opportunity to do meaningful work, grow your career and make a real impact on people’s health around the world. Together, we’re improving health and improving lives. Labcorp is seeking a Quality Auditor, GLP/GCP to join our team in Indianapolis, IN.

Requirements

Bachelor’s Degree in a Pharmacy, Chemistry or Biology related discipline
6 years in regulatory environment in GLP/GCP regulatory environment.
2 years of Auditing experience

Nice To Haves

Postgraduate degree (MSC or equivalent) in science or management related discipline
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 scenarios
Ability to demonstrate effective communication verbally and written with an emphasis on strategic communication with clients.
Excellent organizational and project management abilities.

Responsibilities

Conduct work as identified on the audit activity table (listing on table is not all inclusive but a representative sample)
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 followed