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Clinical Auditing Quality Assurance Specialist

Job ID: 25-08001

Job Title:             Clinical Auditing Quality Assurance Specialist
Duration:            12 months, 40 hrs / week
Location:             Rahway, NJ hybrid

Education: 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 or experience in reviewing GLP data
• Experience working in a GLP environment
• Animal Health Clinical Auditing a plus
• Must have strong communication, organization and writing skills.
• Ability to perform in a multi-task environment.

Software:
• MS office suite
• My learning experience.

Not looking for auditing experience:
• GMP
• IT QA
• IT quality system

Responsibilities:
Position will satisfy the requirements for a Quality Assurance Unit according to the FDA 21 CFR Part 58 Good Laboratory Practice Regulations (GLPs) and Good Clinical Practice Guidance Document (GCPs). The primary focus of this position is to assure that planned and systematic processes are established to ensure that a study and the 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, 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 our company research meets or exceeds all relevant government and company compliance regulations and standards.

MAJOR ACTIVITIES AND RESPONSIBILITIES
• Reviewing Protocols, Protocol Amendments, Data and Reports for animal health GCP and GLP Studies including bioanalytical studies conducted in-house. Familiarity with auditing GLP data in Analyst and Watson LIMS systems is a plus.
• Issues audit reports to the study monitor, study director, investigator, and study management as appropriate. Tracks audit reports. Review audit responses to ensure appropriate actions and documentation has occurred. Distributes audits to management.
• Assist in performing internal facility inspections of Client Animal Health research facilities. Issue reports to department and management.
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