Senior Quality Specialist – III

Job Description

Job Summary:

• 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.

Duties and responsibilities:

Assist in:

• 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 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.

Education:

• Bachelor’s degree with at least 2 years GLP auditing experience in the R & D regulatory compliance environment or 3 years related experience.
• QA R&D auditing or experience in reviewing R&D data
• Experience in a GLP Environment
• Experience in managing department SOPs

Skills and Abilities:

• 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.

Schedule Note:

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