Sr. Quality Assurance Associate (19-00691) – NJ – Woodcliff Lake

Duties:
Support the outsourcing of Clinical Investigator Site Audits
Conduct Trial Master File Audits, Clinical Study Report audits and Internal Process Audits
Assist with health authority inspection preparation and facilitation
Conduct peer reviews of audit reports
Act as a scribe during meetings and author meeting minutes

The position will require independent decision making for (but not limited to) the following:
• Conducting peer reviews of audit reports
• Providing GCP guidance to external customers
• Risk assessments of audit observations and audit observation responses

Education and Skills:
• Bachelor’s degree in associated functional discipline, advanced degree preferred
Clinical Quality Assurance experience
• Fundamental knowledge of US, EU and International regulatory standards and guidelines for the conduct of clinical trials.
• Technical and administrative capabilities to carry out routine audits with minimal supervision or to play a supporting role in more complex audits
• Must be analytical and thorough in work habits and report writing
• Must have mature and professional communications skills, strong independent time management skills and the ability to multi-task
• No travel required
Source: Job Diva – Job Listing

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