QA Auditor

Summary:

The QA Auditor is responsible for carrying out systematic and independent examination (i.e., audit) of multiple study related activities and documents, to determine whether the evaluated study related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, standard operating procedures (SOPs), GLP (21 CFR Part 58 and Part 11) and the applicable regulatory requirements. The QA Auditor is responsible for reporting any findings to the Study Director or Responsible Person and Testing Facility Management.

Duties:

• Autonomously performs audits of Protocols, Amendments/Amended Protocols, raw data, reports, and supporting documentation for internal accuracy, consistency, and conformance with regulations and SOPs.
• Perform audits of equipment qualifications and computerized systems validations projects for accuracy, consistency and conformance with regulations, SOPs.
• Performs phase inspections of ongoing study/project activities.
• Prepares, issues, and tracks reports of observations noted during audits and inspections.
• Performs facility audits to ensure that the facility is in compliance with regulations.
• Acts as lead auditor on studies and projects.
• Maintains computerized files to support audit activities.
• Supports project planning and implementation.
• Provides risk-based compliance opinions and guidance.
• Identifies compliance gaps in processes, systems and studies; influences and collaborates with employees and management.
• Assists with representing Quality Assurance (QA) in internal work groups.
• Recognizes and supports opportunities for functional area improvement.
• Performs Regulatory Review on SOPs.
• Reviews and updates Quality Assurance SOPs as assigned.
• Assists with regulatory training of staff.
• Supports client visits and regulatory agency inspections.

Qualifications:

• Bachelor’s degree or higher in a scientific discipline, or equivalent combination of education and experience.
• Two to three years related technical experience and/or training.
• A minimum of one year auditing in a GLP-regulated environment.
• Professional certification such as RQAP-GLP (Registered Quality Assurance Professional-GLP) or ASQ-CQA (American Society of Quality – Certified Quality Auditor) or other certification is recommended.
• The math skills required include but are not limited to: the ability to utilize appropriate mathematical concepts for interpreting scientific studies.
• Microsoft Office Suite experience required.

Benefits Package Includes:

• Health/Dental/Vision Insurance Plans
• 401(k)/RRSP with Employer Match
• Paid Vacation and Holidays
• Paid Sick and Bereavement Leave
• Employee Assistance & Telehealth Programs
• Telework when applicable