Quality Auditor - GLP/GCP

Labcorp•Indianapolis, IN

3d•Onsite

About The Position

Labcorp is seeking a Quality Auditor, GLP/GCP to join their team in Indianapolis, IN. This role is crucial for ensuring that clinical research laboratory testing operations comply with global regulatory standards and industry-recognized best practices, including GCP/GLP, ISO 15189, ISO 13485, and CAP. The company is a global leader in laboratory services, providing insights and answers to healthcare providers, patients, researchers, pharmaceutical companies, and health systems. Labcorp is committed to advancing diagnostics, accelerating innovation, and addressing global health challenges through science, data, technology, and its laboratory network. They are leveraging advanced technologies, intelligent digital solutions, and data-driven innovation to enhance operations and deliver greater value to customers and patients.

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.
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.