Quality Assurance Coordinator III

Department: Quality & Regulatory Affairs         Job Status: Full-time

FLSA Status: Non-Exempt                                  Reports To: Manager of Quality Assurance/Quality Control Positions Supervised: None

OSHA Risk Category: 2-Medium Risk

POSITION SUMMARY

The Quality Assurance Coordinator III (QAC III) supports the mission, goals and strategic plan of Surgenex through providing regulatory support. The QAC III supports the Quality Assurance/Quality Control Department with performing cadaveric and birth tissue donor chart QA in compliance with FDA regulations, AATB standards, and Surgenex’s policies, procedures. This position demonstrates competency to perform essential job functions of the QAC III position and is responsible for supporting the quality assurance work of the company by performing birth tissue donor chart quality assurance in accordance to Surgenex policy and procedures, requests for additional donor information is documented on partner pending logs, and final compilation and review of relevant donor records is performed prior to submitting to the Medical Director to determine donor eligibility.

ESSENTIAL FUNCTIONS

Essential Functions Statement(s):

• Receives, compiles, and reviews cadaveric and birth tissue donor records ensuring initial minimal required documentation is received from recovery/acquisition agencies to ensure adequate and relevant donor information is received to perform chart quality assurance for Medical Director donor eligibility determination.
• Effectively communicates with the Medical Director(s) to seek guidance for medical and donor record questions. Sends donor records for donor eligibility determination.
• Facilitates requests from recovery/acquisition partners for but not limited to medical record documentation, autopsy reports, death certificates, EMS reports, MARs, serology reports and other information for donor eligibility in accordance with regulatory and accreditation entity requirements as well as Surgenex policy and procedure. Ensures verification of information is performed.
• Ensures timely receipt of documentation from Reports to outside agencies and partners and affected Surgenex staff relevant information, including but not limited to, positive serology reports and positive culture reports.
• The QAC III will be responsible for assisting in employee training and development.
• Maintains positive communication with tissue recovery/acquisition partners. Sends information / documentation requests via the processor pending logs to the recovery/acquisition agencies. May provide final disposition for tissue donors.
• Provides initial, periodic and re-training of quality documentation for birth tissue donor related activities for quality, acquisition, and processing staff.
• Responsible for collaborating with the Finance department to reconcile billing and accounts receivable information against the QA pending charts, the electronic donor medical record, and recovery/acquisition pending logs.
• Assist Quality &Regulatory Affairs with performing quality audits including but not limited to donor consents and uniform donor risk assessment interviews to ensure compliance with Federal, State, International Regulations and accrediting standards, and Surgenex policies and procedures.
• Supports and participates in scheduled and unscheduled tissue partners, regulatory and accrediting agency audits including but not limited to the FDA and AATB.
• Monitors and maintains a current status of donor records using established electronic tracking systems, obtaining additional information as necessary.
• Responsible for supporting the use of systems within the Surgenex Quality Management System and improvement initiatives within the Quality & Regulatory Affairs
• Assists with initiating and conducting investigations and follow-up for reported adverse reactions and Responsible for ensuring all reports are adequately closed and warranted corrective actions are completed.
• Recognizes and reports trends and opportunities for improvement (OFI) regarding donor records, Quality & Regulatory Affairs and organizational metrics to the Sr. Director and Manager of Quality Assurance / Quality Control, or designee.
• Other duties as assigned

Reasonable Accommodations Statement

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

POSITION QUALIFICATIONS

Competency Statement(s) – Position Specific

• Accuracy – Ability to perform work accurately and thoroughly.
• Active Listening – Ability to actively attend to, convey, and understand the comments and questions of others.
• Conflict Resolution – Ability to deal with others in an antagonistic
• Customer Oriented – Ability to take care of the customers’ needs while following company procedures.
• Detail Oriented – Ability to pay attention to the minute details of a project or task.
• Honesty / Integrity – Ability to be truthful and be seen as credible in the workplace.
• Organized – Possessing the trait of being organized or following a systematic method of performing a task.
• Responsible – Ability to be held accountable or answerable for one’s conduct.
• Self-Confident – The trait of being comfortable in making decisions for oneself.
• Time Management – Ability to utilize the available time to organize and complete work within given deadlines.
• Team Builder – Ability to convince a group of people to work toward a goal.
• Communication, Oral – Ability to communicate effectively with others using the spoken word.
• Communication, Written – Ability to communicate in writing clearly and concisely.
• Accountability – Ability to accept responsibility and account for his/her actions.
• Judgment – The ability to formulate a sound decision using the available information.
• Adaptability – Ability to adapt to change in the workplace.
• Diversity Oriented – Ability to work effectively with people regardless of their age, gender, race, ethnicity, religion, or job type.
• Compliance – Ability of the individual to be in accordance with established guidelines, policy, standards or legislation.

SKILLS & ABILITIES

Education: Bachelor’s Degree in biological science or related field preferred or Associate degree and/or equivalent work experience is required.

Experience: Two to four years of related experience in a regulated or certified industry. Must possess excellent working knowledge of medical terminology. Experience with electronic medical records is required.

Computer Skills: Proficient with Mac and Google functions preferred.

Certificates & Licenses: AATB – CTBS preferred.

Other Requirements: Direct healthcare-related experience is preferred. Knowledge of human anatomy and medical terminology required.