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Form of workFormally reports to and receives direction from the Rochester Quality Control Manager in Mayo Clinic Center for Regenerative Biotherapeutics (CRB). Works collaboratively with advanced biomanufacturing, process development, quality, and regulatory staff, as well as Mayo Clinic Principal Investigators and external partners to formulate and establish product performance objectives. The role will work closely with process development and technical transfer and manufacturing staff to meet upstream and downstream outcomes including environmental monitoring, in-process, release and stability testing, leading assay development and validation and driving Quality Control documentation and investigations. The position requires a hands-on approach, being able to work on teams and establish good working relationships with other departments or partners both internally and externally.
The Quality Control Senior Engineer is responsible for performing, analyzing and investigating Quality Control processes, including microbiological testing & environmental monitoring program as well as in-process, release and stability testing, and assay development tasks as directed by supervisor, providing qualification and validation support for manufacturing processes that are essential to the clinical production.
The Sr. QC Engineer will 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. Performs and implements investigations and process improvements including CAPAs and Change Controls. Ensures compliance with all applicable Federal and State accrediting agency requirements in the testing of biopharmaceutical products manufactured in the current Good Manufacturing Practices (cGMP) facility. Leads in optimization and validation of new analytical procedures for testing as necessary and is a subject matter expert (SME) in one or more areas. Responsible for developing, reviewing and revising Standard Operating Procedures as necessary. Perform general laboratory activities as assigned by supervisor. Complete and maintain updated all training required to perform assigned tasks and develops and implements training for others. Performs audits of processes and data and SME for external audits.
As an Affirmative Action and Equal Opportunity Employer Mayo Clinic is committed to creating an inclusive environment that values the diversity of its employees and does not discriminate against any employee or candidate. Women, minorities, veterans, people from the LGBTQ communities and people with disabilities are strongly encouraged to apply to join our teams. Reasonable accommodations to access job openings or to apply for a job are available.
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.
