Job Description

Overview

Provides support to the Quality Assurance and Regulatory Affairs department assisting in donor advocacy tasks as well as audits, inspections and the document control system.

Responsibilities

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.

• Assists with regulatory affairs activities to ensure information is acquired necessary to submit complete regulatory documents for submission in a timely manner.
• Participates and assists in external assessments and inspections
• Participates in the internal audit program to help maintain compliance and create process improvements
• Assists with the document control system to ensure controlled documents, including SOPs/Forms and labels are current and archived appropriately
• Assists with the functions of donor advocacy tasks including but not limited to receiving calls from donors, tracking documents and records, being available as a resource to donor advocacy, QA and donor systems, and Medical Staff.

Qualifications

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:

High school diploma or equivalent and one (1) year experience in a blood bank setting. Prior experience with blood bank systems requirements and procedures preferred.

CERTIFICATES, LICENSES, REGISTRATIONS AND DESIGNATIONS:

None

KNOWLEDGE, SKILLS AND ABILITIES:

• Ability to organize work for timely completion
• 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
• Basic computer knowledge including Microsoft Office applications
• Skill in operating office equipment.

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).

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.

OneBlood is an Equal Opportunity Employer/Vet/Disability/Other Protected Categories