Description

Job Purpose

Manage the overall operation of the Quality Assurance (QA) process, including Donor Eligibility Determination and Final Release of product. Ensure that all donor and batch release responsibilities are performed in accordance with current Standard Operating Procedures and in compliance with federal, state, and local regulations in addition to pertaining accrediting agencies. Manages the continuous review and inspection of donor chart records ensuring the medical record documentation and processing record documentation are assembled compliantly, reviewed and completed in a timely manner. Communicate and coordinate effectively with other departments to meet production and sales needs. Prepare and report on functional area metrics. 

Duties and Responsibilities

1. Ensure compliance with tissue banking regulatory standards including AATB standards, FDA regulations and applicable state requirements.
2. Maintain knowledge of all QA procedures and processes related to donor and tissue tracking systems, current donor acceptance criteria, donor eligibility determination procedures, batch release procedures, and assists in their review and development.
3. Develop, maintain, and report to senior management performance and release metrics.
4. Develop and maintain tracking mechanisms for donors shared with partner agencies to ensure timely chart review and release. Provide reports to senior management when requested.
5. Attend weekly planning meeting as the Quality Assurance representative and work with Operations, Customer Service, Distribution, and all other cross functional departments to ensure commitments and customer needs are met. 
6. Complete nonconformance and corrective and preventive action reports as needed. Support investigation and completion of complaint and adverse reaction reports as necessary.
7. Participate in internal and external audits and audit responses.
8. Interview, hire, train, evaluate and counsel employees.
9. Perform other duties as deemed necessary.

Requirements

Qualifications

Bachelor’s degree in a medical or science related field preferred. Two years of experience in Quality Assurance in tissue banking, organ procurement or other related healthcare industry preferred. Excellent interpersonal, telephone, verbal and written communication skills required. Must have experience supervising staff in a manner conductive to top performance and high morale. Must be detail oriented, organized, accurate, and able to multi-task, problem solve and give recommendations. Knowledge of Good Manufacturing Practice and Good Tissue Practice regulations preferred.

Working conditions

Office oriented work environment. Must be willing to work weekends and evening hours as necessary.

Physical requirements

While performing the duties of this job, the employee may be required to sit or stand for prolonged periods of time. The employee may occasionally be required to pull, lift and/or move up to 25 pounds. 

Direct reports

Donor Eligibility Supervisor, Donor Eligibility Team Lead, Donor Eligibility Specialists, Final Release Supervisor, Final Release Team Lead(s), Batch Record Reviewers, QA Record Coordinator, Records Associate. 

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.