GLP/GCP Toxicology Quality Assurance Auditor

Labcorp•Madison, WI

2d•Onsite

About The Position

Labcorp is a leader in diagnostics, drug development and healthcare innovation. Across every role, we harness data and AI to work smarter, move faster and create breakthrough solutions that improve health outcomes for people. With our global scale and deep expertise, you'll do meaningful work, grow your career and make a real impact. Together, we're improving health and improving lives. Join our Labcorp Quality department as a Toxicology Quality Auditor in Madison, WI. The individual in this role verifies compliance to standard operating procedures (SOPs) and regulations by performing study protocol, data, report, and in-lab phase audits (where applicable) for specific study types and gain experience by participating in internal facility/process and/or supplemental inspections. The statements below reflect the general responsibilities and requirements of the identified position but may not describe all the work requirements that may be inherent in the job. It is the responsibility of all employees to comply with all applicable regulations e.g. Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) in the performance of their role. Labcorp is a leading global life sciences company that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers, and patients make clear and confident decisions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and improve lives. Here, you can join our nearly 70,000 employees, serving clients in more than 100 countries, as we work together to transform approaches to patient care.

Requirements

Minimum: Bachelor’s Degree in Life Sciences preferred (or equivalent Life Science experience)-Experience may be substituted for education
2 years in a GLP/GCP regulatory environment
Ability to apply basic relevant regulatory knowledge
Ability to follow instruction e.g. QA documents (SOPs)
Ability to assimilate/interpret operational documents such that audit can be performed to required level
Ability to critically assess data and apply procedures and regulations
Adaptability to an ever-changing work environment
Ability to recognize gaps in procedures and regulations and consult with more senior QA individuals
Demonstrated ability to apply critical thinking skills

Nice To Haves

One-year experience with GLP: 21 CFR Part 58

Responsibilities

Conduct basic foundational audit activities such as, but not limited to protocol review, and internal facility/process and/or supplemental inspections
Provide timely notification to management regarding identification of critical issues
Build and maintain successful relationships on a one-to-one basis.
Answers questions relating to audit findings
Participate in liaison meetings and audit finding negotiations
Make suggestions for improving compliance and/or efficiency of the local QA organization and business units supported
Ensure Regulatory Compliance and Quality Assurance responsibilities, as indicated in applicable controlled documents, are followed
Other duties as assigned by management
Verifies compliance to standard operating procedures (SOPs) and regulations by performing study protocol, data, report, and in-lab phase audits (where applicable) for specific study types
Gain experience by participating in internal facility/process and/or supplemental inspections