Quality Analyst - FDA Regulated Manufacturing

Mayo Clinic • Rochester, MN

2d • Onsite

About The Position

The Quality Analyst, FDA Regulated Manufacturing is responsible for the implementation of quality and regulatory compliance for product manufacturing activities. The Quality Analyst directs the work to identify and reduce regulatory, accreditation, and compliance risk by continuously monitoring and evaluating current facility policies and practices to ensure compliance is built into the operational systems. This role is accountable for the effective implementation of the Quality Management System (QMS) and serves as the local 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. This position may be required to take direction from management staff across multiple departments and develop expertise in multiple types of products manufactured at Mayo Clinic (i.e., medical devices, tissues, cellular therapies, etc.).

Requirements

• Bachelor's degree, preferably in a science-related field (e.g., biology, chemistry, etc.).
• Minimum of 5 years of experience in a quality-related field.
• Exceptional human relations and communication (written, verbal, and listening) skills.
• Organizational project management skills.
• Analytical and critical thinking skills.
• Must be flexible and capable of adapting to and facilitating change.
• Should be very detail-oriented.
• Ability to work independently and productively with minimal direction.
• Routinely exercise initiative and sound judgment.
• Ability to lead, motivate and influence others.
• Objectivity and professionalism.
• Demonstrated capacity to comprehend complex protocols, programs, and situations.
• Ability to exercise good judgment in ambiguous situations while under pressure and tight deadlines.
• Strong coping skills.
• Must be flexible in adapting to a variety of responsibilities, work assignments, and priorities.
• Must also be flexible with work schedule as needed to meet customer needs.
• Must be self-motivated and able to independently schedule workday activities with minimal direction.
• Must be U.S. citizen, permanent resident, refugee or asylee.

Nice To Haves

• Knowledge and experience in the application of laws, regulations, and guidance documents related to FDA regulated industries (biologics, pharmaceuticals, etc.).
• Previous experience with FDA GMPs, EU regulations, and/or ISO certification for product manufacturing.
• Knowledge of quality systems (e.g. SOPs, audits, documentation practices, etc.).
• Experience working in a research environment.
• ASQ certification in quality and/or GMP principles (e.g., quality process analyst, quality improvement associate, etc.) are strongly encouraged.

Responsibilities

• Implementation of quality and regulatory compliance for product manufacturing activities.
• Identify and reduce regulatory, accreditation, and compliance risk by continuously monitoring and evaluating current facility policies and practices.
• Ensure compliance is built into the operational systems.
• Effective implementation of the Quality Management System (QMS).
• Serve as the local subject matter expert on the policies, processes, and procedures of the QMS.
• Develop a broad knowledge of the practice, business, and technology as it relates to product manufacturing.
• Take direction from management staff across multiple departments.
• Develop expertise in multiple types of products manufactured at Mayo Clinic (i.e., medical devices, tissues, cellular therapies, etc.).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level