Job Description

Title: Quality Systems Auditor (GLP & GCP)

Location: Rahway, NJ

Duration: 08+ Months (Possible Ext or Conversion)

Job Description:

• It will satisfy the requirements for a Quality Assurance Unit (QAU) according to the FDA 21 CFR Part 58 Good Laboratory Practice Regulations (GLPs) and the VICH GL9 Good Clinical Practice Guidance Document (GCPs).

The primary focus of this position is to act as a Quality Assurance coordinator to assist in the following tasks:

• Managing the QA SOPs
• Managing QA training documentation
• Coordinating Auditor schedules for CRO and Internal Inspections
• Archival of QA documentation
• QA metrics
• Creating and distributing the list of outstanding QA audit reports
• This position will also assist in assuring that planned and systematic processes are established to ensure that the study data are collected, documented, and reported are in compliance with the GLPs and GCPs or other applicable regulatory requirements, as well as study protocols, SOPs, and industry guidance and standards.
• This position is key to the completion of final study reports for GCP and GLP studies required for submission to CVM, USDA or international regulatory agencies. A thorough and expeditious audit process is necessary for meeting high-quality submission requirements.
• This position is required in assuring our company research meets or exceeds all relevant government and company compliance regulations and standards.

Major activities and responsibilities include:

• QA SOP management
• QA training documentation management
• Coordination of schedules for CRO and Internal Inspections
• Archival of QA documentation
• QA metrics
• Creating and distributing the list of outstanding QA audit reports
• Assist in performing internal facility inspections of client research facilities.

Assist in:

• Auditing GLP or GCP regulated studies:
• Protocols/ Protocol Amendments
• Study Data
• Stat Reports
• Final Study Report
• Issue audit reports to the study monitor, study director, investigator, and study management as appropriate. Tracks audit reports.
• Reviews audit responses to ensure appropriate actions and documentation has occurred. Distributes audits to management.

Qualifications

• Bachelor’s degree with at least 2 years GLP auditing experience in the R & D regulatory compliance environment or 3 years related experience.

Must haves:

• QA R&D auditing or experience in reviewing R&D data
• Experience in a GLP Environment
• Experience in managing department SOPs
• Animal Health Clinical Auditing a plus
• Must have strong communication, organization and writing skills.
• Ability to perform in a multi-task environment.
• MS office suite

If you are not interested in looking at new opportunities at this time I fully understand. I would in that case be appreciative of any referrals you could provide from your network of friends and colleagues in the industry. We do offer a referral bonus that I’d be happy to extend to you if they turn out to be a great fit for my client.

Thank you for your time and for your consideration. I look forward to hearing from you.

Job Tags

Similar Jobs