Senior Quality Auditor

Advanced Recruiting Partners; Quebec; On-site; CAD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Quality Auditor to join their dynamic team. This role involves conducting audits, ensuring compliance with GxP regulations, and mentoring junior auditors. The ideal candidate will have a strong background in quality assurance, excellent organizational skills, and the ability to communicate effectively with diverse stakeholders. This is a fantastic opportunity to contribute to a leading firm while enhancing your expertise in a collaborative environment. If you're passionate about quality assurance and ready to take on new challenges, this position is perfect for you.

Qualifications

• Extensive experience in GxP quality assurance auditing.
• Excellent knowledge of GxP regulatory requirements.

Responsibilities

• Writes and issues audit reports, ensuring clear communication.
• Serves as Lead Auditor on team-based internal audits.

Skills

GxP quality assurance auditing

Organizational skills

Interpersonal skills

Problem-solving

Presentation skills

Cultural sensitivity

Education

Bachelor’s degree in a science/healthcare field

Tools

Microsoft Office

SharePoint

Job description

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• Writes and issues audit reports, ensuring clear communication of audit findings to the auditees and relevant management.
• Reviews responses to audit findings for appropriateness and completeness.
• Closes assigned audits.

Customer Audits/Inspections

• Prepares for and hosts or supports customer audits.
• Prepares for and hosts or supports Regulatory Authority Inspections.

Other Responsibilities

• Serves as Lead Auditor on team-based internal audits.
• Serves as a trainer and mentor to less experienced QA auditors.

Supervision

• Requires minimal instructions on day-to-day work and new assignments.

Additional Tasks

• May write, review or revise QA Standard Operating Procedures (SOPs) / Work Instructions (WIs).
• Performs other work-related duties as assigned.
• Moderate travel may be required (up to 50%).

Qualifications

What We’re Looking For

• Bachelor’s degree in a science/healthcare field or equivalent with extensive experience in GxP quality assurance auditing.
• Previous experience in conducting multiple audit types (e.g., vendors, investigator sites, trial master files, data management, safety reporting, and laboratories) is preferred.
• Excellent knowledge of GxP regulatory requirements.
• Knowledge of medical and technical terminology related to the audit types to be conducted.
• Computer literacy appropriate to job requirements (Microsoft Office suite; basic SharePoint proficiency).
• Able to handle multiple tasks to meet timelines in a dynamic environment.
• Strong organizational, presentation, and interpersonal skills.
• Cultural sensitivity to allow effective communication with stakeholders from diverse backgrounds.
• Ability to negotiate, problem-solve, and provide constructive feedback.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research and Quality Assurance

• Industries

  Staffing and Recruiting

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