Lab Quality Specialist - Human Cellular Therapy Lab
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. 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.
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
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
