Senior Quality Assurance Auditor
J
JobgetherClinical research
This position can be performed remotely from anywhere in CanadaFull-TimeSenior
SalaryEstimated annual salary range of $100,000–$140,000
Apply NowOpens the employer's application page
Job Details
- Experience
- At least 6 years of quality assurance experience within a clinical research environment; significant and sustained performance in a relevant non-QA role may be considered as an alternative.
- Required Skills
- Microsoft Office
Requirements
- Bachelor’s degree in health sciences, physics, biology, mathematics, or a related discipline.
- At least 6 years of quality assurance experience within a clinical research environment; significant and sustained performance in a relevant non-QA role may be considered as an alternative.
- Quality auditor certification through ASQ, ISO, or an equivalent organization is preferred.
- Experience supporting preparation for or hosting regulatory inspections is preferred, ideally with at least one year of relevant exposure.
- Strong knowledge of clinical trial processes, procedures, and operational practices.
- Comprehensive understanding of pharmaceutical and clinical research regulations, including FDA, Health Canada, and European Medicines Agency requirements.
- Strong knowledge of ICH and Good Clinical Practice (GCP) guidelines.
- Solid understanding of QA and QC processes, procedural document management, auditing methodologies, and training practices.
- Analytical, investigative, and problem-solving skills, attention to detail, and ability to identify inconsistencies.
- Conflict-resolution and interpersonal skills, with the ability to communicate effectively across organizational levels.
- Ability to manage multiple priorities while maintaining concentration and accuracy over extended periods.
- Proficiency with Microsoft Office applications.
Responsibilities
- Conduct scheduled internal audits to evaluate compliance with regulatory requirements, clinical research standards, and established SOPs.
- Document, communicate, and report audit findings within required timelines.
- Lead corrective and preventive action investigations and monitor compliance issues through resolution.
- Maintain governing and procedural documentation, tracking records, database updates, review obligations, and follow-up activities.
- Support preparation for client audits and regulatory inspections, providing quality assurance expertise.
- Perform vendor qualification assessments, coordinate assessment activities, and follow up on observations.
- Deliver training on quality assurance procedures and support consistent application of QA practices.
- Follow up with project and study teams on study-specific training, project kick-off activities, and sponsor-specific procedures.
- Research industry trends, regulatory developments, and quality best practices.
- Identify opportunities to strengthen quality systems, improve processes, and promote consistent compliance.
View Full Description & ApplyYou'll be redirected to the employer's site
