Job Purpose:
Performs functions necessary to assure that Vivex Biologics, Inc. is in compliance with all applicable regulations and/or standards of regulatory and accrediting agencies. Performs functions necessary to assure that all relevant donor eligibility documentation are assembled, reviewed, and completed in a timely manner. Performs continuous review and inspection of donor chart records and ensures that such records are in the state of compliance with all applicable requirements of regulatory and accrediting agencies. Performs functions in accordance with standard operating procedures, all applicable state, and regulatory requirements.
Duties and Responsibilities
Donor Eligibility Review:
Responsible for assembling all relevant records for review for the determination of donor eligibility.
Reviews and completes records ensuring compliance with applicable SOPs, agency requirements, accreditation standards, and regulations.
Retrieves all event-related documentation from hospitals, emergency medical services, medical examiners, etc., in a timely manner.
Communicates with appropriate personnel on missing required documentation, error corrections, and autopsy reports that are required to ensure complete chart creation for Quality Assurance, Medical Director Review, and resource sharing with partner agencies.
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 deviation reports, as needed.
Participates in audits and inspections, as needed.
Performs other duties as assigned by the Supervisor and/or Director of Quality Assurance and Regulatory Affairs.
Requirements:
Bachelor's degree preferred. An equivalent combination of education and experience in a medical environment familiar with medical terminology will be considered. Excellent interpersonal, telephone, verbal, and written communication skills required. Demonstrated excellence in organizational and record keeping skills required. Must be detail oriented. Familiarity with regulations regarding Tissue Banking preferred. Must gain knowledge of all regulations, laws, and/or standards that govern the tissue banking industry. Must demonstrate advance computer skills in Microsoft platform.
Working Conditions:
Primarily a quiet office oriented work environment. 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
