WE ARE LOOKING FOR QUALIFIED CANDIDATES FOR OUR BOCA RATON, FLORIDA LOCATION ONLY. THIS IS NOT A REMOTE POSITION.
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.
The Quality Assurance Coordinator assists the Director, Quality Assurance and Regulatory Compliance with ongoing activities related to the development, implementation, maintenance of, and adherence to, the organization’s quality assurance policies and procedures in compliance with applicable federal and state laws and accreditation standards.
Bachelor’s Degree preferred; or the equivalent in education and work experience
Under the guidance and direction of the Director, Quality Assurance and Regulatory Compliance, the Quality Assurance Coordinator shall:
- Assist in promoting and maintaining a quality culture throughout the organization.
- Conduct internal QA audits and prepare reports including trending and analysis.
- Assist with development of training and documentation for Donor Services and Apheresis Facility staff.
- Assist with supplier evaluation monitoring for the Apheresis Facility and Registry Donor Services.
- Establish and maintain Supplier qualification files.
- Assist with investigation and resolution of deviations and complaints, including root cause analysis, corrective and preventative actions and effectiveness checks.
- Assist with procedural updates.
- Assist with temperature monitoring for all controlled temperature storage areas.
- Maintain and update equipment and approved supplier lists.
- Maintains QA related documents and reports.
- Participate in continual improvement activities to enhance the Quality Management System.
- Assist, as needed, in the document review and manufacturing release process for cellular therapy products.
- Develop a working knowledge of all areas of the organization and a clear understanding of the organization’s key functional processes and resources.
- Other duties as assigned.
Knowledge, Skills and Experience
- Excellent customer service and communication skills
- Understanding of 21 CFR current Good Manufacturing Practices and current Good Tissue Practices and other applicable local, state and federal regulations.
- Knowledge, training and experience in QA principles and data management systems.
- Evidence of understanding and monitoring of compliance with SOPs.
- Proficient in Microsoft Office Suite and other data management software.
- Good project management skills.
- Good analytical skills.
- Ability to work independently on tasks assigned.
- Must work well under pressure.
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 management requires to meet the ongoing needs of the organization.
Please attach your resume and cover letter via email to firstname.lastname@example.org.