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).

• 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

• 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.

• 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.

• Hybrid 3 days onsite - (Tuesday and weds onsite core days, choice of Monday or Thursday for third onsite day)