US-NC-Durham: QA Associate
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• Acts as clinical site auditor for contracted client site audits. Prepares audit plans, conducts audits, and writes audit reports for QA Director approval and submission to clients. When contracted, enters audit findings into the CAPA system and follows up with the audited site to ensure timely and effective actions.
• Assists the Director, Quality with coordinating and hosting Client and ISO registrar audit visits. Coordinates agendas, assists visitors with audit arrangements, takes and publishes audit minutes. Provides responses to auditors’ questions regarding QA processes and procedures, and coordinates activities with audit interviewees.
• Prepares management information packages for quarterly Quality System Management Review Meetings, takes meeting minutes and publishes results.
• Acts as backup to the QA Director, presenting ISO and QMS information during new employee corporate orientation.
• Assists with performance of final QA review of proposals to ensure proper composition, spelling, grammar, consistency, coherence and sensibility.
• Performs other duties as assigned.
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Team SQAFYI - Software QA Resource FYI