Clinical Quality Assurance

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POST DATE 8/12/2016
END DATE 12/29/2016

ADPI LLC New Haven, CT

New Haven, CT
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #


Clinical Quality Assurance AP5307701New Haven, CT 5 Month Contract Duties:Develop
and implement quality management plan for each assigned program Interpret
and provide key metrics to Global Development Team Leader and cross-functional
development team members Support GCP SOP development and serve as quality
operations reviewer.Execute risk-based methodologies for the planning and
execution of clinical protocols assuring an ongoing cycle for Plan ? Do
? Check ? Act Manage quality issues including audit reports, quality issues/incidents,
and CAPA development, working closely with RDQ audit team and clinical
development. Ensure timely implementation and closure of CAPAs.Facilitate
the assessment and investigation of quality issues, by driving root cause
analysis and remediation. Provide expertise and recommendations. Ensure
timely review and closure of quality issues.Assure appropriate escalations
and notification to line management Lead inspection readiness and inspection
preparation activities, including SME training/preparation and back room
activities, and manage back room during GCP inspections. Analyze the risks,
propose the strategy for readiness and manage the implementation of readiness
program. Provide lessons learned after each GCP inspection.Use knowledge
of GCP, clinical development, and industry best practices in order to provide
guidance, training and input to business partners on compliance issues.
Able to adapt precedent and develop creative and effective soluti


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