Quality Assurance Specialist- Hybrid

Looking for animal health GCP auditing experience. • Animal health GLP auditing experience. Job Title: Quality Specialist- II -Hybrid Job Location: Rahway NJ Duration: 2 years Provide QA oversight for a Global Research & Development organization. Serve as the Quality Assurance Unit (QAU) in compliance with VICH GL9 (GCP), FDA 21 CFR Part 58, and EPA 40 CFR Part 160 (GLP). Key Responsibilities Conduct GLP/GCP study, facility, data, and report audits (internal & external) Issue and track audit reports; ensure resolution of findings Review bioanalytical studies (LC/MS-MS preferred); audit GLP data in LIMS systems Audit CROs supporting GCP/GLP studies Support FDA, EPA, and corporate inspections Review and develop SOPs; ensure regulatory compliance Provide GLP/GCP training and workload reporting to management Strong knowledge of FDA bioanalytical method validation guidance required Description

SCOPE MEASURES

This position is key to the completion of final study reports for GCP and GLP studies required for submission to CVM, EPA, and international regulatory agencies. A thorough and expeditious audit process is necessary for meeting high-quality submission requirements. This position is required in assuring MAH research meets or exceeds all relevant government and company compliance regulations and standards.

BACKGROUND REQUIREMENTS

Bachelor’s degree with 5 years related experience, with at least 2 years auditing experience in the regulatory compliance environment, Must have strong communication, organization and writing skills. Knowledge of VICH GCP Guidelines, FDA, EPA and OECD GLPs. Ability to perform in a multi-task environment; ability to facilitate and/or lead a variety of meeting formats. Note Hybrid 3 days onsite - (Tuesday and weds onsite core days, choice of Monday or Thursday for third onsite day) #J-18808-Ljbffr AllSTEM Connections