Senior Quality Analyst: Quality Systems, CAPA & Audits Lead

Quantum Technologies. LLC; Madison, Northern (WI, KY); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Quantum Technologies LLC in the United States is seeking a Quality Systems professional to develop and maintain quality system processes, ensure CAPA effectiveness, and support regulatory compliance across the site in Madison, Wisconsin.

The role focuses on facilitating Change Management, root cause analysis, training on Good Documentation Practice, and coordination of internal and external audits to uphold the highest quality standards.

Qualifications

• Develop and maintain quality system processes.
• 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.

Responsibilities

• Develop and maintain quality system processes, including metrics reporting and tracking.
• Manage CAPA initiation, review, surveillance, and reporting.
• Facilitating site Quality Management reviews.
• Lead the site Change Management process.
• Support and lead root cause analyses through cross functional team involvement.
• Lead Good Documentation Practice training and Quality on the Floor coordination.
• Interpret and apply regulatory requirements.
• Coordinate and support facility audits by internal and external entities.
• Manage data collection and reporting for product recalls.
• Perform trending of Quality Systems for FDA and Management reviews.
• Improve quality culture and procedures to align with regulatory requirements.
• Review and approve procedures, protocols, reports, etc.
• Filing and management of documentation.
• Support other Quality System Functions.
• Lead personnel within the Quality organization when needed.

Job description

Quantum Technologies LLC in the United States is seeking a Quality Systems professional to develop and maintain quality system processes, ensure CAPA effectiveness, and support regulatory compliance across the site in Madison, Wisconsin.

The role focuses on facilitating Change Management, root cause analysis, training on Good Documentation Practice, and coordination of internal and external audits to uphold the highest quality standards.