Senior Quality Analyst/Engineer
Cloud Analytics Technologies LLC
Job Description :
Develop and maintain quality system processes, including metrics reporting and trackingManage CAPA initiation, review, surveillance, and reporting
Facilitate the site Quality Management reviews
Facilitate and lead the site Change Management process
Support and lead root cause analyses through cross functional team involvement
Leading Good Documentation Practice training and Quality on the Floor coordination and performance
Interpret and properly apply all applicable regulatory requirements
Coordinate and provide direct support for facility audits by internal and external entities
Manage data collection and reporting when product recalls are required
Perform trending of Quality Systems to support FDA and Management reviews
Improve quality culture through site initiatives and improve existing procedures to better align with regulatory requirements
Review and approval of procedures, protocols, reports, etc., as required.
Department specific/Non-essential responsibilities:
Filing and management of documentation when required
Supporting other Quality System Functions
This role may be required to lead personnel (inside and outside) the Quality organization in support of the business need
Vacancy posted 11 days ago
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