Quality Assurance Records Analyst

Donor Network of Arizona•Tempe, AZ

12d•$24 - $28

About The Position

About the Quality Assurance Records Analyst The Quality Assurance Records Analyst (QARA) performs level-specific quality assurance (QA) review of eye, tissue, and/or organ donor records according to Donor Network of Arizona (DNA) standards, customer and partner expectations, and accreditation and regulatory requirements. Each level assumes competencies of the essential job function of the previous level. All donor records are reviewed to ensure compliance with the appropriate requirements depending on donor type, including but not limited to DNA Standard Operating Procedures, US Food and Drug Administration (FDA), Eye Bank Association of America (EBAA), American Association of Tissue Banks (AATB), and other affiliated programs. QARAs ensure that discrepancies, errors, or missing information as identified, that corrections are made by the appropriate parties, and that all necessary follow-up information is obtained, as requested by affiliate programs. The QARA ensures that processing partners and transplant centers are provided with all donor information required to help ensure the safety of recipients of donated organs, eyes, and tissues. QARAs coordinate and facilitate professional working relationships with internal and external colleagues, demonstrating subject matter expertise for the applicable quality assurance standards and associated regulations. In addition, the QARAs support the DNA Quality and Regulatory Compliance program through participation and/or leadership of assigned projects, such as process improvement, audits, or trainings.

Requirements

High School Diploma or GED
0 - 6 Months experience
General knowledge of biological sciences
General knowledge of medical terminology

Nice To Haves

Bachelor’s Degree
2+ Years’ experience

Responsibilities

Performs daily quality assurance review of donor charts and associated data entry to ensure accuracy, timely completion and compliance with DNA Standard Operating Procedures (SOPs) and regulatory requirements.
Compiles, monitors, and processes donor record documentation to ensure a complete donor record.
Ensures adequate resolution of any identified discrepancies or documentation errors.
Consults with appropriate resources as necessary to obtain required relevant donor information.
Maintains real-time documentation of donor chart status, for traceability and ability to readily identify pending items. Ensures that all necessary follow-up information is obtained, as required by DNA tissue and eye processing partners, transplant centers, regulatory bodies, and DNA Standard Operating Procedures.
Performs daily review and timely resolution of information requests received from affiliated tissue and eye processors, organ transplant centers, and research partners.
Ensures timely resolution of ongoing information requests / pending log items from affiliated tissue and eye processors.
Acts as a primary quality liaison for assigned processor and/or transplant programs.
Supports the use of quality systems and improvement initiatives related to donor record integrity, process effectiveness and efficiency, and overall fulfillment of the Donor Network of Arizona mission and goals.
Consistently demonstrates the use of good documentation practices.
Resolves assigned donor record review findings accurately and within the pre-established timeframes.
Resolves assigned nonconformance corrective / preventive action items accurately, thoroughly, and within the pre-established timeframes.
Logs nonconformances in an appropriate manner for identified deficiencies, accurately documenting the occurrence within the quality management software.
Participates in the quality improvement process within DNA, as defined in the Skill Set / Competency section.
Actively shares ideas for improvement in a positive manner.
Works collaboratively and maintains open communication and professional relationships.
Maintain open verbal and written communication and works collaboratively with internal and external colleagues.
Regularly communicates with department leadership regarding issues that may impact the effective and efficient performance of the QA process, including but not limited to recurring chart errors and pending follow-up items.
Fosters healthy working relationships between DNA departments and outside organizations.
Keeps current with QARA level-specific standards and regulations, such as FDA regulations, EBAA Standards, AATB Standards, and UNOS/OPTN Policies.
Actively participates in continuing education opportunities, including QA specific training sessions, DNA organizational offerings, and external webinars, conferences, and classes.
Completes assigned SOP learning events within pre-established timeframes.
Supports, reinforces, and exhibits behaviors consistent with the core values of DNA.
Acts as a role model for the Quality and Regulatory Compliance team and all of DNA by supporting, reinforcing, and exhibiting behaviors consistent with the core values of DNA.
Performs other duties as requested or required by Quality Department Leadership.