Senior Quality Control Engineer

The Mayo Clinic Center for Regenerative Biotherapeutics (CRB) is seeking a Senior Quality Control Engineer with a strong background in microbiology, including hands-on experience with various bacteria, fungi, yeast, and their growth conditions. The ideal candidate will have experience working in a cGMP-regulated environment with background in microbiological testing, environmental monitoring and sound knowledge of sterility, bioburden, and endotoxin testing’s scientific principles.

Will be responsible for trending, reviewing, and writing environmental monitoring data reports for the facility. Assisting with the scheduling and monitoring of routine and non-routine microbiological testing of materials and cell therapy products (growth promotion, endotoxin, mycoplasma, sterility) performing quality control assays (release, in-process, stability), and supporting assay development and validation.

Perform all GMP related activities strictly according to SOPs with accurate and complete documentation associated with the testing, in compliance with cGMP, principles of Data Integrity and good documentation practices.

• A master’s degree in a biomedical related field (biology, chemistry/biochemistry, laboratory medicine, etc.) with at least 2 years research experience within a laboratory environment; or a bachelor’s degree in a biomedical related field and a minimum of 5 years relevant experience. cGMP environment work experience in clinical manufacturing of biologics or products intended for human use is preferred.
• Must have strong technical understanding and experience developing assays. 
• Ability to analyze data and compose reports. 
• Ability to effectively communicate complex ideas to a variety of shareholders across functions through multiple forms of communications. 
• An understanding of the application of laws, regulations, and guidance documents related to FDA regulated biologics, pharmaceuticals, devices, etc. 
• Exceptional human relations and communication (written, verbal, and listening) skills. 
• Flexibility and capable of adapting to and facilitating change. 
• Must demonstrate capacity to comprehend complex protocols, programs, and situations. 
• Ability to exercise good judgment while working under deadlines is required.
• Must be flexible with work schedule as needed to meet internal and external customer needs.

Visa sponsorship is not available for this position.  This position is not eligible for F-1 OPT STEM extension.

Why Mayo Clinic
Mayo Clinic is top-ranked in more specialties than any other care provider according to U.S. News & World Report. As we work together to put the needs of the patient first, we are also dedicated to our employees, investing in competitive compensation and comprehensive benefit plans – to take care of you and your family, now and in the future. And with continuing education and advancement opportunities at every turn, you can build a long, successful career with Mayo Clinic. You’ll thrive in an environment that supports innovation, is committed to ending racism and supporting diversity, equity and inclusion, and provides the resources you need to succeed.