Job Description

The Quality Analyst, FDA Regulated Manufacturing is responsible for 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 continuous monitoring and evaluating current facility policies and practices to ensure compliance is built into the operational systems. 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.).

Qualifications

A bachelor's degree is required, preferably in a science related field (e.g. biology, chemistry, etc.) and a minimum of 5 years of experience in a quality-related field. Knowledge and experience in the application of laws, regulations, and guidance documents related to FDA regulated industries (biologics, pharmaceuticals, etc.) and previous experience with FDA GMPs, EU regulations, and/or ISO certification for product manufacturing is preferred, along with knowledge of quality systems (e.g. SOPs, audits, documentation practices, etc.). Exceptional human relations and communication (written, verbal, and listening) skills are required. Organizational project management skills are essential, along with analytical and critical thinking skills. Must be flexible and capable of adapting to and facilitating change. Should be very detail-oriented and have the ability to work independently and productively with minimal direction, and routinely exercise initiative and sound judgment. Must have the ability to lead, motivate and influence others. Compliance issues may create difficult situations for the individuals involved; therefore, objectivity and professionalism is essential. Must have demonstrated capacity to comprehend complex protocols, programs, and situations. The ability to exercise good judgment in ambiguous situations while under pressure and tight deadlines, and strong coping skills are required. 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. Experience working in a research environment is preferred. Must be self-motivated and able to independently schedule workday activities with minimal direction. ASQ certification in quality and/or GMP principles (e.g., quality process analyst, quality improvement associate, etc.) are strongly encouraged.

Note: Visa sponsorship is not available for this role. Must be U.S. citizen, permanent resident, refugee or asylee.