Quality Assurance Coordinator- Tissue

Are you ready to save a life?

Do you want to be the person that makes the miracle of organ donation a reality? Do you want to turn tragedy into hope and healing?This is what we do every single day and we think you have what it takes.

Join a team that combines the fulfillment of an amazing mission with incredible benefits. This is not just another job or listing on your resume. Simply put, this job will change you, just like organ, eye and tissue donation and transplantation changes the lives of donor families and recipients.

Every day, the Lifebanc team gets the opportunity to change lives forever. Become a part of our family as we work toward a world where everyone in need of an organ or tissue transplant receives the healing they deserve. Come be a life saver.

What is Lifebanc?

Lifebanc, is the federally designated organ, eye and tissue recovery organization that serves 20 counties in Northeast Ohio. Put simply, we facilitate and coordinate organ, eye and tissue donation and transplantation in our community and educate the public on the importance of our mission. Our vision is pursuing a future where organ, eye and tissue donation is embraced as an honor and personal responsibility. Our mission is to save and heal lives.

Position Description:

This position is responsible for compliance with AATB, AOPO, EBAA, FDA, and CMS standards, and to ensure timely and accurate quality review of tissue and eye donor charts, tissue processor data, Electronic Medical Records (EMR) data, and any other data entry associated with Lifebanc local tissue and eye donors.

Essential Functions:

Maintains compliance with AATB, AOPO, EBAA, FDA (cGTP) and CMS standards that govern eye and/or tissue recovery and associated charting in the EMR.

Independently reviews and completes initial and/or final QA review of all tissue and eye donor files post recovery within required timeframes Independently completes a review of recorded authorizations and/or disclosures and donor risk assessment interviews. Ensures required clinical data has been collected and documented in all EMR charts for accurate reporting and analysis of organizational performance measures.

Educates all new hire staff responsible for tissue chart documentation to ensure accurate training in organ, eye and tissue chart completion.

Provides one on one training for new staff and ongoing training for incumbent staff on accurate charting and industry charting requirements as well as electronic charting requirements, on an as needed basis. Prepares weekly charting issue reports for meetings as needed.

Collaborates with the Health Information/QA Specialist for data entry into Lifebanc's EMR, and/or tissue processor websites to ensure accurate and timely completion.

Validates that cultures, biopsies, and/or serology's are properly reported to transplant centers and tissue processors within required timeframes. Ensures that accurate and verified data for tissue processors are submitted within the required timeframes.

Responds to calls from tissue processors, OPOs, donor hospitals, transplant centers and other individual inquiries regarding tissue donation and its associated outcomes to comply with AATB, AOPO, CMS, FDA and UNOS standards.

Investigates and resolves tissue/eye donor case issues as identified by Tissue Processor and/or Eye Bank QA staff. Addresses tissue processor inquiries (i.e. QIs and pending logs) in a timely manner

Maintains assigned Lifebanc Tissue and Eye Chart Review and Reporting policies to ensure that they are up to date and accurate.

Writes/revises changes to assigned SOPs as needed. Assures changes are appropriately communicated with all Lifebanc staff involved in the process.

Conducts internal and/or external audits according to Quality Systems policy to ensure compliance with 21 CFR part 1271 core Good Tissue Practices (cGTP), AOPO and AATB standards.

Participates in the Internal/External Quality Audit Program. Completes/conducts audits according to the Standard Operating Procedure.

Qualifications:

Bachelor's degree required in health sciences, biology, or equivalent job experience. At least 5 years in a GMP or GTP environment such as blood banking, pharmaceutical, medical devices, or hospital environment. Two years course work- or job-related experience in QA, QC or Quality Auditing. CPTC and/or CTBS certification required at time of hire or required to obtain certification within 2 years of hire ASQ, Auditor Certification (CQA) preferred, not required

Compensation and Benefits:

When you join Lifebanc you can expect competitive salaries and a great benefit package. Our benefits include health, dental and vision insurance, health savings account, short-term disability and life insurance. We also offer a generous paid time off program, 401(K) retirement plan, parental leave, on-site fitness facility, tuition reimbursement and more!

Lifebanc is committed to a workforce that is diverse, inclusive and equitable. We encourage qualified candidates to apply.