WE ARE LOOKING FOR QUALIFIED CANDIDATES FOR OUR BOCA RATON, FLORIDA LOCATION ONLY. THIS IS NOT A REMOTE POSITION.

Our Mission

Gift of Life Marrow Registry cures blood cancer through cellular therapy. We believe every person battling blood cancer deserves a second chance at life — and we are determined to make it happen. We are singularly passionate about engaging the public to help us get everyone involved in curing blood cancer, whether as a donor, a volunteer, or a financial supporter. It all begins with one remarkable person, one life-changing swab, and one huge win — finding a match and a cure.

Employment Type

Full-time

Department

Quality Assurance

Education

• Bachelor's Degree
• Certification in Quality Auditing, Lean/Six Sigma, Project Management, or equivalents desirable. 

Summary Statement

The Quality Assurance Specialist assists the Director, Quality Assurance and Regulatory Compliance with oversight of the Quality Management System, (QA/QC, cGMP, cGTP, and cGLP) ensuring that systems and procedures are compliant with applicable federal and state laws and regulations and accreditation standards.

Responsibilities

Under the guidance and direction of the Director, Quality Assurance and Regulatory
Compliance, the Quality Assurance Manager shall:

• Assist in promoting and maintaining a quality culture throughout the organization.
• Assist with the re-certification activities (AABB, FACT, CLIA), federal registrations and state licensing applications.
• Assist with investigation and resolution of deviations, complaints and adverse reactions, including root cause analysis, corrective and preventative actions and effectiveness checks.
• Assist in the document review and manufacturing release process for cellular therapy products.
• Ensure validation plans exist and are executed according to internal SOPs, as well as external regulations.
• Analyze audit outcomes and monitor corrective and preventative actions.
• Maintain QA related documents and reports.
• Participate in continual improvement activities to enhance the Quality Management System across all departments (Donor Services, Apheresis Center, Cellular Therapy Laboratory and Gift of Life Biologics).
• Develop a working knowledge of all areas of the organization and a clear understanding of the organization’s key functional processes and resources.
• Fulfill other duties as assigned.

Knowledge, Skills and Experience

• 3-5 years of experience in cGLP, cGMP, and cGTP (i.e., stem cell or bone marrow processing) with 1-3 years of experience specifically in Quality Assurance. 
• Working knowledge of AABB standards, FACT Common Standards for Cellular Therapy, 21 CFR 210 & 211, and FDA cGMP and cGTP regulations.
• Working knowledge and skills in quality management in the field of cell therapy processing and cryopreservation.
• Experience in quality systems in cellular therapy laboratories and manufacturing.
• Must be detail-oriented and able to set priorities.
• Demonstrate ability to manage and prioritize multiple projects and meet deadlines.
• Possess strong oral and written customer service and communication skills. Must be able to remain calm and tactful when resolving problems involving all levels of staff,patients, visitors, vendors, etc.
• Adept at problem-solving and decision-making.
• Flexible and adaptable to changing conditions.
• Knowledge of statistical analysis to improve quality.
• Good project management skills.
• Knowledge, training and experience in QA principles and data management systems.
• Evidence of understanding and monitoring of compliance with Standard Operating Practices.
• Proficient in Microsoft Office Suite and other data management software.
• Excellent time management, organizational skills, and ability to set priorities.
• Experience interacting with regulatory bodies a plus.
• Demonstrated ability to work independently as well as part of an integrated team.

Physical Demands

This position is basically sedentary with some walking, standing, stooping and lifting required. May lift objects weighing from 0 to 20 lbs. with occasional lifting of objects over 20 lbs. Some travel may be required.

This job description is not intended to be all inclusive. Duties and/or responsibilities may be added or deleted as Executive Management requires to meet the ongoing needs of the organization.

APPLY NOW 

Please attach your resume in an email to barby@giftoflife.org.