QA Auditor

LabCorp•Madison, WI

57d•Onsite

About The Position

Join our Labcorp Quality department as a Quality Auditor in Madison, WI. Are you wanting to move your career into the Quality department? This is a full-time benefitted, day position at the Madison, Wisconsin facility in the Quality department auditing the Immunology and Immunotoxicology work. Take your career to another level maintaining Quality! Join an exceptional organization and an exceptional Quality department. Job Summary: 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 21 CFR Part 58 Good Laboratory Practice (GLP) in the performance of their role.

Requirements

Bachelor's Degree in Life Sciences preferred (or equivalent Life Science experience)
Experience may be substituted for education
Experience with plate reading technologies (e.g. MesoScale, EliSpot, BioPlex)
Understanding of cell viability and cell potency testing
General understanding of principles of flow cytometry
2 years in a regulatory environment
Knowledge of and ability to interpret apply (applicable) regulations to monitor compliance
Able to interpret data and identify quality critical problems
Able to convey regulatory expectations

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