Sr. QA Auditor
The Judge Group Inc.

Job Info

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Location: Paramus, NJ
Salary: $120,000.00 USD Annually - $140,000.00 USD Annually
Description: Our client in the biopharmaceutical industry is currently seeking a Sr. QA Auditor

This candidate will be responsible for, but not limited to the following under the guidance of the Quality Assurance Head and designees:

•SOP Administration, including writing, reviewing, and distributing SOPs.

•Document Reviews (e.g., Protocols, Informed Consents, Study Reports)

•Corrective and Preventive Action (CAPA) tracking

•Conducting Internal and System Audits

•Support Inspection Readiness activities

•Support Training initiatives

•Process Improvement activities

•Providing regulatory guidance and support to dedicated study teams

If interested in applying or for more information, please email RSamuels@judge.com

This job will have the following responsibilities:

• Drafts new SOPs, and updates current SOPs. SOP Administration, which includes collecting comments on SOPs and distributing SOPs through Agatha, an automated system, and its associated training.
• Conducts document reviews of Protocols, Informed Consents, Study Reports, Internal Audit Reports, etc.
• Corrective and Preventive Action (CAPA) tracking. Provides guidance and assistance in the development of corrective action commitments and performs regular follow-up.
• Performs audits of investigator sites, vendors, departments, processes, and systems, both internally and externally against NS Pharma Standards and applicable regulatory requirements.
• Supports Health Authority Inspection training and preparedness.
• Takes an active role in Health Authority Inspections.
• Develops and conducts internal GxP training programs.
• Supports ongoing development and operation of the quality function and the GxP Quality Management System.
• Contributes to corporate quality related goals and objectives.

Qualifications & Requirements:

• B.S. or B.S./M.S. in Chemistry, Biology, or related fields.
  
• Minimum 3-5 years of auditing or diverse experience in the pharmaceutical industry or is able to demonstrate required skills and knowledge.
  
• The applicant for this position will be stationed in the Paramus, NJ office.
  
• Current knowledge of applicable regulations from FDA and international agencies.
  
• In depth knowledge in Clinical Audit processes.
  
• Strong experience in GCP Quality Systems.
  
• Experience in Investigations, Root Cause Analysis, CAPA and Effectiveness check processes, tools, and techniques.
  
• Experience with risk management principles and processes.
  
• Experience with change management principles and processes.
  

Contact: rsamuels@judge.com

This job and many more are available through The Judge Group. Find us on the web at www.judge.com

This job has expired.