Donor Eligibility - Musculoskeletal Team Lead

VIVEX BIOLOGICS INC•Miami, FL

11d•Hybrid

About The Position

It is the responsibility of Donor Eligibility (DE) Musculoskeletal (MS) Team Lead to oversee the timely review, maintenance, and retention of donor records for the donor eligibility team. This person will perform continuous review and inspection of donor chart records and ensure that such records comply with all applicable requirements of regulatory and accrediting bodies. This role will work alongside other departments/agencies to ensure all requirements for donor eligibility determination are met as well as completion of investigations for any deviations/nonconformances/variances/etc. that impact DE. This role will be responsible for performing functions in accordance with Standard Operating Procedures, all applicable state, and regulatory requirements.

Requirements

Applicants must be legally authorized to work in the United States. Vivex will not provide sponsorship or employment for candidates who require the 24-month STEM Optional Practical Training (OPT) extension. Please note this is not an offer of immigration sponsorship
Excellent interpersonal, telephone, verbal, and written communication skills required.
Demonstrated excellence in organizational and record keeping skills required.
Must be detail oriented, organized, able to multi-task, and problem solve.
Must demonstrate advanced computer skills in Microsoft platform.

Nice To Haves

Bachelor’s degree preferred.
An equivalent combination of education and experience in a medical environment familiar with medical terminology will be considered.
Knowledge of Good Manufacturing Practice and Good Tissue Practice regulations preferred.
Must gain knowledge of all regulations, laws, and/or standards that govern the tissue banking industry within first year in position.

Responsibilities

Assist in data management to provide accurate metrics on the DE team’s performance.
Work with Donor Services, Operations, Customer Service, Distribution, Quality Control, and other cross-functional departments to ensure commitments and customer needs are met (e.g. attend the planning meetings).
Maintain the flow of work including, but not limited to, tracking priority donors, pending list items for outside agencies, and aging donors.
Work with internal and external agencies to assist DE team in ensuring that all pertinent documentation for donor chart review is present including, but not limited to, serological and microbial testing, medical records, and autopsy reports
Work with DE team and cross functional departments to correct and prevent errors to minimize disruptions and chart review times
Provide guidance and training to other members of the DE team.
Assist QA management (e.g. Donor Eligibility Supervisor, QA Manager, etc.) with team and project activities.
Ensure Certificates of Conformity/Assurance are completed accurately for timely distribution of tissue.
Oversee donor discards, notifications, and Outside Agency invoicing processes
Participates in continuous quality improvement activities as needed.
Maintains knowledge of and supports Vivex Biologics, Inc. policies and procedures.
Maintains knowledge of appropriate regulatory, statutory, accreditation requirements, and current Good Tissue Practices.
Responsible for reporting all variances, errors, and deviations on all Vivex Biologics, Inc. initiated documentation to QA management.
Participates in the investigation, implementation of corrective actions, and documentation of complaint files and nonconformance reports, as needed.
Participates in Medical Review Board, audits, and inspections, as needed.
Performs other duties as assigned by QA management.