Senior Quality Analyst – FDA Regulated Manufacturing

Mayo Clinic•Rochester, MN

2d•$85,467 - $128,253

About The Position

The Sr. Quality Analyst, FDA Regulated Manufacturing is responsible for oversight of quality and regulatory compliance for product manufacturing activities. The Sr. Quality Analyst directs the work to identify and reduce regulatory, accreditation, and compliance risk by continuous monitoring and evaluating current facility policies and practices to ensure compliance is built into the operational systems. Oversees manufacturing compliance by making interpretations and developing executive summaries of regulatory and compliance information, maintaining registration information, communication with external regulatory and accreditation agencies. The Sr. Quality Analyst communicates and works effectively with leadership to take necessary actions to mitigate identified risks; Is accountable for the effective implementation of the Quality Management System (QMS); and serves as the subject matter expert on the policies, processes and procedures of the QMS by developing a broad knowledge of the practice, business and technology as it relates to product manufacturing.

Requirements

Senior Quality Analyst – FDA Regulated Manufacturing experience
Oversight of quality and regulatory compliance for product manufacturing activities
Identify and reduce regulatory, accreditation, and compliance risk
Continuous monitoring and evaluating current facility policies and practices
Ensure compliance is built into the operational systems
Oversee manufacturing compliance
Making interpretations and developing executive summaries of regulatory and compliance information
Maintaining registration information
Communication with external regulatory and accreditation agencies
Communicate and work effectively with leadership
Take necessary actions to mitigate identified risks
Accountable for the effective implementation of the Quality Management System (QMS)
Serve as the subject matter expert on the policies, processes and procedures of the QMS
Developing a broad knowledge of the practice, business and technology as it relates to product manufacturing

Responsibilities

Oversight of quality and regulatory compliance for product manufacturing activities.
Identify and reduce regulatory, accreditation, and compliance risk by continuous monitoring and evaluating current facility policies and practices.
Ensure compliance is built into the operational systems.
Oversee manufacturing compliance by making interpretations and developing executive summaries of regulatory and compliance information.
Maintain registration information.
Communicate with external regulatory and accreditation agencies.
Communicate and work effectively with leadership to take necessary actions to mitigate identified risks.
Accountable for the effective implementation of the Quality Management System (QMS).
Serve as the subject matter expert on the policies, processes and procedures of the QMS by developing a broad knowledge of the practice, business and technology as it relates to product manufacturing.