GLP/GCP Toxicology Quality Assurance Auditor

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

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

Preferred Qualifications

• 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
• Recognize gaps in procedures and regulations and consult with more senior QA individuals
• Demonstrated ability to apply critical thinking skills

Qualifications

• Minimum Required: 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
• Experience with GLP: 21 CFR Part 58
• 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

Benefits

• Medical
• Dental
• Vision
• Life
• STD/LTD
• 401(k)
• Paid Time Off (PTO) or Flexible Time Off (FTO)
• Tuition Reimbursement
• Employee Stock Purchase Plan

Company Information

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.

About the Role

At Labcorp, it’s our people that make us great – it’s what our clients, our partners and, most importantly, what our employees say. Here, you’ll have the opportunity to work with extraordinary people with diverse viewpoints. You’ll discover your own outstanding potential as we build an even stronger organization with industry leaders from early development to the clinic and beyond. We help our clients develop medicines that improve health and improve lives of their family and friends. All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data.

Why Work at Labcorp?

Labcorp is Proud To Be An Equal Opportunity Employer Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law. We encourage all to apply If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement.