GLPGCP 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 worlds 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 youll have the opportunity to do meaningful work grow your career and make a real impact on peoples health around the world. Together were 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: Bachelors 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 its our people that make us great its what our clients our partners and most importantly what our employees say. Here youll have the opportunity to work with extraordinary people with diverse viewpoints. Youll 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 bebased on a candidates skills and prior relevant experience applicabledegrees/certificationsas 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 regularly scheduled to work less than 20 hours Casual Intern and Temporary employees are only eligible to participate in the 401(k) more detailed information pleaseclick here.

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

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