Quality Analyst FDA Regulated Manufacturing

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.).

A bachelors 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.