QA Specialist/Auditor

Frontage Laboratories•Chicago, IL

6h•Onsite

About The Position

The individual in this position supports studies of the safety and/or toxicity of various materials (e.g., pharmaceuticals, chemicals, etc.). The QA Specialist/Auditor monitors study activities, facilities, equipment, personnel, procedures, and pertinent records to ensure that they satisfy appropriate domestic and international Good Laboratory Practice regulations, customer specifications and the company’s standard operating procedures.

Requirements

Must have a minimum of BS/BA degree in basic or applied science (biology, chemistry, etc.) with at least 1-2 years of experience in the conduct of GLP audits.

Responsibilities

Work under the supervision of the Senior Director of Quality Assurance.
Conduct audits of pre-clinical toxicology or analytical chemistry studies to ensure strict compliance with GLP (FDA, EPA, OECD and JMHW) regulations, Study Protocol, and Company’s SOPs.
Audit study reports and records for completeness and consistency to confirm that reported results reflect the raw data and study methods. Identify compliance weaknesses and assist with the implementation of workable solutions.
Inspect subcontractor facilities to ensure compliance with GLPs. Serve on various internal committees (e.g., computer validation, SOP review, etc.) to provide a QA perspective on the issues discussed.