Clinical Quality Assurance 9/16/2016

ADPI LLC New Haven, CT

Company
ADPI LLC
Job Classification
Full Time
Company Ref #
silentAP5307701
AJE Ref #
576199188
Location
New Haven, CT
Job Type
Temporary

JOB DESCRIPTION

APPLY
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

Requirements

Not Specified

Apply for this Job at:
http://www.net-temps.com/job/4vv6/AP5307701/clinical_quality_assurance_.html?r=aje

This job is posted by Net-Temps, Inc. Search over 100,000 jobs
with free Resume posting and your personal Job Seekers Desktop.