Remote QA Auditor II - Clinical Research Quality Assurance Expert
Join our team as a Remote QA Auditor II and play a critical role in ensuring the quality and integrity of clinical research programs. We are seeking a highly skilled and experienced QA Auditor to conduct complex internal and external audits, identify areas for improvement, and develop strategies to address issues. As a key member of our team, you will have the opportunity to work remotely from anywhere in the US and contribute to the success of our clinical research quality assurance initiatives.
This is a fantastic opportunity for a seasoned QA professional to grow their career and make a meaningful impact in the clinical research industry. If you have a strong background in GCP, auditing, and clinical trials, and are passionate about delivering high-quality results, we encourage you to apply for this exciting role.
Key Responsibilities:
- Conduct complex internal and external Clinical Research Site audits to ensure compliance with established quality assurance processes, standards, global regulatory guidelines, and client contractual obligations.
- Identify issues impacting the quality and/or integrity of clinical research programs, determine root cause of non-conformance, and develop strategies to address issues.
- Perform technical document review and other GCP practice activities in support of clinical development programs.
- Provide audit reports to management and plan and deliver quality services, including contracted quality assurance audits, internal site audits, laboratory and file audits for clients and projects.
- Lead process/quality improvement initiatives, mentor peers, and develop tools and materials for tracking compliance management activities and analyzing trends.
Requirements:
- Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
- Previous Clinical Site Auditing experience (2+ years) or equivalent combination of education, training, and experience.
- Must have GCP and auditing experience for clinical trials.
- Thorough knowledge of applicable GCP and regional regulations, as well as strong knowledge of the clinical trial process.
- Excellent oral and written communication skills, strong attention to detail, and ability to work independently or in a team environment.
What We Offer:
- Competitive salary and benefits package.
- Opportunity to work remotely from anywhere in the US.
- Professional development and growth opportunities in a dynamic and supportive team environment.
Join Our Team!
If you are a motivated and experienced QA professional looking for a new challenge, please submit your application today. We look forward to hearing from you!
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