Senior Quality Analyst/Engineer

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

Job Description :
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

Equal Opportunity Employer
CLOUD ANALYTICS TECHNOLOGIES LLC is an equal opportunity employer inclusive of female, minority, disability and veterans, (M/F/D/V). Hiring, promotion, transfer, compensation, benefits, discipline, termination and all other employment decisions are made without regard to race, color, religion, sex, sexual orientation, gender identity, age, disability, national origin, citizenship/immigration status, veteran status or any other protected status. CLOUD ANALYTICS TECHNOLOGIES LLC will not make any posting or employment decision that does not comply with applicable laws relating to labor and employment, equal opportunity, employment eligibility requirements or related matters. Nor will CLOUD ANALYTICS TECHNOLOGIES LLC require in a posting or otherwise U.S. citizenship or lawful permanent residency in the U.S. as a condition of employment except as necessary to comply with law, regulation, executive order, or federal, state, or local government contract

Some of our Business Ventures - Knowledge Analytics

Do restrictive necessities, your capability for advanced analytics or your business model need custom-made applications and infrastructure configurations? opt for our hosted managed services to urge comprehensive analytics solutions supported industry-leading Cloud Analytics Technologies, LLC code - delivered by the Cloud Analytics Technologies, LLC consultants UN agency understand these solutions best. Through a mix of with-it technology and dedicated service and support, Cloud Analytics Technologies, LLC hosted managed services will facilitate you: