Labcorp Quality department is looking for a BioA Quality Auditor to ensure regulatory compliance and quality assurance within their BioA department in Madison, WI.
Requirements
- 1 year in a GLP regulatory environment, BioA and LCMS
- 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
- Ability to recognize gaps in procedures and regulations and consult with more senior QA individuals
Responsibilities
- Follow applicable policies and SOPs
- Navigate to the regulations and able read/understand specific regulations
- Conduct audits as directed
- Timely notification to management regarding identification of critical issues
- Make suggestions for improving compliance and/or efficiency of the local QA organization and business units supported
- Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed
Other
- Successful relationships on one-to-one basis.
- Able to answer questions relating to audit findings (successful interaction/relationships on small scale outside QA function)
- Adaptability to an ever-changing work environment
- A minimum of a Bachelor’s Degree in Life Sciences preferred (or equivalent Life Science experience)
- Experience may be substituted for education.
