GLP/GCP Toxicology Quality Assurance Auditor

Labcorp•Madison, WI

8d•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. Join our Labcorp Quality department as a Toxicology Quality Auditor in Madison, WI.

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

Nice To Haves

One-year experience with GLP: 21 CFR Part 58
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

Responsibilities

Navigate to the regulations and able to read/understand specific regulations
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 and gain experience by participating in internal facility/process and/or supplemental inspections.