Lab Quality Specialist - Human Cellular Therapy Lab

Why Mayo Clinic Mayo Clinic is top-ranked in more specialties than any other care provider according to U.S. News & World Report. We are dedicated to our employees with competitive compensation and comprehensive benefits, and opportunities for growth and education. Benefits Highlights Medical: Multiple plan options. Dental: Delta Dental or reimbursement account for flexible coverage. Vision: Affordable plan with national network. Pre‑Tax Savings: HSA and FSAs for eligible expenses. Retirement: Competitive retirement package to secure your future. Responsibilities Develop and maintain the quality management plan, SOPS, document approvals. Coordinate and participate in audits and inspections. Investigate, trend, and follow up on errors and incidents, lead CAPA processes. Manage deviations, review batch records, conduct risk assessments. Monitor compliance with FACT and FDA standards and support accreditation readiness. Collect, prepare, and analyze monthly departmental monitors. Coordinate and document proficiency testing activities. Contribute content to Performance Improvement Committees. Assist with internal and external audits. Develop, coordinate, and document Quality System Essential Program. Coordinate department improvement projects. Qualifications Bachelor of Science degree. Minimum two years of medical laboratory experience. Additional Qualifications Minimum 2 years of experience in a cellular therapy laboratory (preferred) or at least 4 years of regulatory experience in a clinical blood bank. Strong written, verbal, and interpersonal communication skills. Strong organizational skills and self‑initiative. Patience and ability to coach and mentor others. Proficiency with personal computers for word processing, spreadsheets, data management, charts, and presentations. Teamwork, initiative, and project management skills. Familiarity with quality tools such as LEAN, Six Sigma, DMAIC. Knowledge of laboratory safety and regulatory compliance. Ability to facilitate meetings. Preferred Experience Experience in cell therapy processing laboratory (required). Knowledge of FACT standards and FDA GTP (highly preferred). Experience with regulatory audits (highly desired). Compensation Salary range: $73,736.00 – $110,552.00. Schedule Full time, Monday – Friday, 8 am–5 pm. 80 hours per pay period. Weekend work required as needed, rarely. #J-18808-Ljbffr Mayo Clinic