Senior Quality Analyst - QMS, CAPA & Audit Lead

Cloud Analytics Technologies, LLC; Madison (WI); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Equal Opportunity Employer

Job summary

Cloud Analytics Technologies, LLC in Madison, WI seeks a QA professional to lead quality system processes, CAPA, audits, and regulatory compliance. The role includes cross-functional root cause analyses, Good Documentation Practice training, and Quality on the Floor coordination to strengthen the site's quality culture.

The ideal candidate will interpret regulatory requirements, support facility audits, manage data reporting for recalls, and drive improvements to align procedures with regulatory

Responsibilities

• Develop and maintain quality system processes, including metrics reporting and tracking
• Manage 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.
• 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

Job description

Cloud Analytics Technologies, LLC in Madison, WI seeks a QA professional to lead quality system processes, CAPA, audits, and regulatory compliance. The role includes cross-functional root cause analyses, Good Documentation Practice training, and Quality on the Floor coordination to strengthen the site's quality culture.

The ideal candidate will interpret regulatory requirements, support facility audits, manage data reporting for recalls, and drive improvements to align procedures with regulatory