Lab Quality Specialist - Human Cellular Therapy Lab

Mayo Clinic•Phoenix, AZ

7d•$73,736 - $110,552•Onsite

About The Position

This position is responsible for quality oversight of the Human Cellular Therapy lab. Responsibilities include but not limited to 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, and supporting accreditation readiness and inspections.

Requirements

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

Responsibilities

Collects, prepares, and analyzes monthly departmental monitors.
Coordinates and documents proficiency testing activities.
Contributes content to Performance Improvement Committees.
Assists with internal and external audits.
Assists in development, coordination, and documentation of Quality System Essential Program.
Coordinates department improvement projects.