Lab Quality Specialist - Human Cellular Therapy Lab

Mayo Clinic•Phoenix, AZ

7d•$73,736 - $110,552

About The Position

Mayo Clinic is a leading healthcare provider, recognized for its excellence in patient care and employee dedication. We offer competitive compensation, comprehensive benefits, and opportunities for career advancement. This position is specifically for the Human Cellular Therapy lab, focusing on quality oversight and compliance with industry standards.

Requirements

Bachelor of science degree.
Minimum two years of medical laboratory experience.
Experience in cell therapy processing lab is required.
Strong written, verbal, and interpersonal communication skills.
Strong organizational skills and self-initiative.
Patience and the ability to effectively coach and mentor others.
Familiarity with personal computers for word processing, spreadsheet preparation, data collection/management/analysis, and creation of graphs/charts and presentation slides.
Ability to work as a team member, take direction from others, and initiate and manage projects.
Working knowledge of laboratory safety and regulatory compliance.
Ability to facilitate meetings as required.

Nice To Haves

A minimum of 2 years of experience in a cellular therapy laboratory setting preferred, or alternatively, at least 4 years of regulatory experience in a clinical blood bank preferred.
Familiarity with quality tools such as LEAN, Six Sigma, DMAIC, etc.
Knowledge of FACT standards and FDA GTP highly preferred.
Experience with regulatory audits is highly desired.

Responsibilities

Developing and maintaining the quality management plan.
Managing SOPs, form and document approvals.
Coordinating and participating in audits.
Occurrence management, investigating, trending, and follow-up of errors and incidents.
Leading CAPA processes.
Managing deviations.
Reviewing batch records.
Conducting risk assessments.
Monitoring compliance with FACT and FDA standards.
Supporting accreditation readiness and inspections.
Collecting, preparing, and analyzing monthly departmental monitors.
Coordinating and documenting proficiency testing activities.
Contributing content to Performance Improvement Committees.
Assisting with internal and external audits.
Assisting in development, coordination, and documentation of Quality System Essential Program.
Coordinating department improvement projects.