Quality Assurance Specialist 1

Join LifeLink Join a Life Saving Team! About LifeLink More than four decades ago, a visionary group of innovators, led by renowned nephrologist Dr. Dana Shires, made a life-changing commitmentto save lives through organ and tissue donation. From that bold beginning, LifeLink Foundation was established - founded with heart, purpose, and a mission that still guides us today. What started as a nonprofit with big dreams has grown into a vision-driven organization of more than 700 dedicated professionals across west-central Florida, Georgia, parts of South Carolina, Puerto Rico, and the US Virgin Islands. At LifeLink, we are united by our mission: To honor donors and save lives through organ and tissue donation. Our vision remains clear: To maximize the gift of life while giving hope to donor families and transplant patients. We are grounded in the values that shape our work and culture Compassion. Excellence. Legacy. People. Quality. If you're inspired by purpose, driven by impact, and ready to help save and heal lives, LifeLink is the place for you. What You'll Do As a Quality Assurance Specialist 1, you will directly contribute to LifeLink's life-saving mission. The Quality Assurance Specialist 1 is an individual contributor responsible for supporting the Quality Assurance (QA) program at LifeLink Tissue Bank (LLTB), which includes the Audit system (internal and external), and the Quality Incident system (errors, deviations, non-conformances, complaints, adverse events, and CAPA initiation). Key Responsibilities: Works as an individual contributor responsible for supporting the Audit system, which includes performing, hosting, reporting, tracking, and facilitating the resolution of audits (internal and external.) Works as an individual contributor supporting the Quality Incident system, which includes the identification, tracking, facilitation, investigation, reporting and completion of Quality Incident Reports (e.g., deviations, non-conformances, complaints, adverse events, etc.) Collaborates to support continuous improvement projects within their scope of work. Works collaboratively with other departments to lead root cause investigations, facilitate problem-solving activities, and projects. Supports the vendor qualification process. Facilitates, documents, and ensures the resolution of Environmental Alert/Action Reports as assigned. Assists with the development and delivery of training content within their area of responsibility. Assists with developing and maintaining controlled documents within their area of responsibility. Participates in special projects and other assignments as directed. Who You Are Passionate about helping others and making a difference Aligned with LifeLink's core values of Compassion, Excellence, Legacy, People, and Quality A bachelor's degree or equivalent in a scientific discipline is required. A minimum of three years of experience in an industry that is regulated by the US Food and Drug Administration is required. Certification by the American Association of Tissue Banks, and the American Society for Quality are preferred. Advanced computer skills required (Microsoft Office, Adobe, software-as-a-service platforms.) Requires excellent verbal and written communication. A collaborator who thrives in a mission-first environment Working Conditions: Work requires extended hours during peak processing and/or procurement periods. Office space and equipment will be provided to perform necessary duties. Hazardous conditions include, but are not limited to, the possible exposure to microorganisms, viruses, potentially infectious body fluids and hazardous chemicals. OSHA Risk Classification: High Why LifeLink? Be part of an organization with a legacy of saving lives and giving hope Join a passionate and supportive team across Florida, Georgia, and Puerto Rico COMPANY PAID Medical, Dental, Disability & Life Insurance Generous COMPANY PAID Pension Plan for your Retirement Paid Vacation, Sick Days & Holidays Growth opportunities in a mission-driven, high-impact nonprofit Work with purpose, knowing your efforts directly touch lives Diversity, Equity & Inclusion LifeLink is proud to be an equal opportunity employer. We celebrate diversity and are committed to building an inclusive environment that reflects the communities we serve. Ready to Help Change Lives? Your next career move could be the most meaningful one yet.