Lab Quality Specialist - Human Cellular Therapy Lab

About the role

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.

Responsibilities

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

Qualifications

• Bachelor of science degree.
• Minimum two years of medical laboratory experience.
• Minimum two years of experience in a cellular therapy laboratory setting preferred, or alternatively, at least four years of regulatory experience in a clinical blood bank preferred.
• 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.
• Familiarity with quality tools such as LEAN, Six Sigma, DMAIC, etc.
• Working knowledge of laboratory safety and regulatory compliance.
• Ability to facilitate meetings as required.
• Experience in cell therapy processing lab is required.
• Knowledge of FACT standards and FDA GTP highly preferred.
• Experience with regulatory audits is highly desired.

Exemption Status

Exempt

Compensation Detail

Compensation range is $73,736.00 - $110,552.00/ salary.

Benefits Eligible

Yes

Schedule

Full Time

Hospital/Location

Phoenix, Arizona