Quality Assurance Specialist, Biovigilance

Performs quality assurance and regulatory work with focus on the biovigilance process. Conducts analysis of non-conforming donation test results, post donation information (PDI), adverse event reports and reentry requests and notifies appropriate parties in accordance with organizational SOP and regulatory standards. Completes documents and reports required for compliance and regulatory submissions.

The list of essential functions, as outlined herein, is intended to be representative of the duties and responsibilities performed within this classification. It is not necessarily descriptive of any one position in the class. The omission of an essential function does not preclude management from assigning duties not listed herein if such functions are a logical assignment to the position.

• Performs notifications to hospitals, physicians and donors associated with non-conforming Autologous and Directed donations
• Submits Department of Health notification and FDA Biologic Product Deviation Reports in accordance with regulatory requirements and organizational policies and procedures.
• Evaluates non-conforming donation test results and post donation information (PDI); performs market withdrawal and recall in accordance with organizational SOPs and regulatory standards
• Assists with disease surveillance programs
• Reviews and approves eligibility for re-entry of previously deferred donors
• Notifies applicable donors of positive and/or abnormal donor test results and adverse transfusion events
• Investigates reports of suspected transfusion reaction complications

To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

EDUCATION AND/OR EXPERIENCE

Associates Degree in biological science or related field and three (3) years of experience in blood bank setting; or an equivalent combination of education, certification, training, and/or experience. Prior experience with blood bank systems requirements and procedures preferred.

CERTIFICATES, LICENSES, REGISTRATIONS AND DESIGNATIONS

None

KNOWLEDGE, SKILLS AND ABILITIES

• Basic computer knowledge including Microsoft Office applications
• Ability to formulate, initiate, and administer policies and procedures for effective fiscal control
• Ability to travel up to 50% of the time
• Ability to follow complex oral and written instructions
• Ability to communicate effectively orally and in writing
• Ability to establish and maintain effective and cooperative working relationships with those contacted in the course of work
• Ability to commute with personal transportation.
• Ability to organize work for timely completion
• Skill in operating office equipment
• Ability to work with minimal supervision
• Knowledge of and ability to interpret and apply federal, state and accrediting agency regulations

PHYSICAL REQUIREMENTS

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Ability to exert light physical effort in sedentary to light work, which may involve some lifting, carrying, pushing and/or pulling of objects and materials of light weight (up to 20 pounds). May involve some climbing, balancing, stooping, kneeling, crouching, crawling, walking or standing.

ENVIRONMENTAL REQUIREMENTS

The work environment characteristics described here are representative of those an employee may encounter while performing the essential functions of this job.

Functions are regularly performed inside without potential for exposure to adverse conditions, such as inclement weather, atmospheric elements and pathogenic substances. The noise level in the work environment is usually moderate.