Donor Eligibility - Musculoskeletal Team Lead

Vivex Biologics; Miami (FL); Hybrid; USD 85,000 - 120,000; Full time

Job summary

Vivex Biologics, Inc. is seeking a Donor Eligibility (DE) Musculoskeletal (MS) Team Lead to oversee timely review, maintenance, and retention of donor records, ensuring regulatory compliance and readiness for audits across departments.

The role guides the DE team, coordinates with QA and external agencies, and drives continuous quality improvement while adhering to SOPs and applicable state and regulatory requirements.

Qualifications

• Bachelor's degree preferred; equivalent combination of education/experience considered.
• Excellent interpersonal, verbal and written communication required.
• Must be detail oriented and able to multi-task.
• Proficiency with Microsoft Office suite required.

Responsibilities

• Assist in data management to provide metrics on the DE team’s performance.
• Coordinate with Donor Services, Operations, Customer Service, Distribution, Quality Control and other cross-functional departments to meet commitments.
• Maintain the flow of work including tracking priority donors, pending items for outside agencies, and aging donors.
• Coordinate with internal and external agencies to ensure documentation for donor chart review is complete.
• Work with DE team to correct and prevent errors to minimize disruptions and review times.
• Provide guidance and training to other members of the DE team.
• Assist QA management with team and project activities.
• Ensure Certificates of Conformity/Assurance are completed for tissue distribution.
• Oversee donor discards, notifications, and Outside Agency invoicing processes.
• Participate in continuous quality improvement activities as needed.

Skills

Interpersonal skills

Communication skills

Organizational skills

Multi-tasking

Problem solving

Education

Bachelor’s degree preferred

Tools

Microsoft Office

Job description

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.

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

Duties and responsibilities

Donor Eligibility Review

• 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.

Quality Assurance

• 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.

Qualifications

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

Education and Experience: 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.

Other Skills: 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.

Working conditions

Office oriented and remote work environments. Some evening and weekend work may be required. Facility temperatures are maintained cool.

Physical Requirements

While performing the duties of this job, the employee is regularly required to sit for prolonged periods of time. The employee may occasionally be required to pull, lift, and/or move up to 20 pounds.

Direct reports

No direct reports

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job any time.

Vivex Biologics, Inc. is an equal opportunity employer (EEO) and expressly prohibits any form of workplace discrimination and/or harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, transfers, leaves of absence, compensation, and training.

Vivex Biologics, Inc. complies with the Americans with Disability Act (ADA) which prohibits discrimination against qualified individuals with disabilities who, with or without reasonable accommodation, can perform the essential functions of a job.