GLP/GCP Toxicology Quality Assurance Auditor

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.

Responsibilities/Duties:

• 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

Minimum Required:

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

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.

Why People choose to work at Labcorp?

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. 

Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Employees regularly scheduled to work less than 20 hours, Casual, Intern, and Temporary employees are only eligible to participate in the 401(k) Plan. For more detailed information, please click here. 

Labcorp is proud to be an Equal Opportunity Employer:

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