QA Auditor - BioA

Labcorp•Madison, WI

3d•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 Quality Auditor - BioA Work Schedule: Monday Through Friday 8-5 pm in Madison, WI 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, participate in internal facility/process and/or supplemental inspections, and peer review QA SOPs. 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.

Requirements

A minimum of a Bachelor’s Degree in Life Sciences preferred
Experience may be substituted for education.
Understanding of chromatography (i.e. HPLC)
Experience with mass spectrometry/hybrid tandem mass spectrometry instrumentation
Knowledge of and ability to interpret and apply (applicable) regulations in order to monitor compliance
Ability to interpret data and identify quality critical problems
Able to convey regulatory expectations

Nice To Haves

2 years in regulatory environment (experience in GXP roles) BioA and/or LCMS
1-year expereince BioA and LCMS

Responsibilities

Conduct, but not limited to protocol review, report/data audits, and internal facility/process inspections
Peer review QA SOPs
Support operational liaison meetings representing QA function
Report on relevant quality metrics (for single topics/departments) and highlight trends
Ensure Regulatory Compliance and Quality Assurance responsibilities, as indicated in applicable controlled documents, are followed
Other duties as assigned by management
Support 'business partner' /liaison meetings representing QA function with operations (local)
Adhere to required timeline on assigned activities