Quality Assurance Assistant

Provides administrative, operational, and compliance support to the Quality Assurance & Regulatory Affairs department. Assists with quality system activities including document control, audits, inspections, corrective and preventive action (CAPA) tracking, regulatory compliance, records management, donor advocacy, and continuous improvement initiatives. Supports the organization's commitment to donor safety, product quality, regulatory compliance, and operational excellence.

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.

Supports the department by maintaining quality records, databases, and compliance tracking systems
• Assists with internal audits, external audits, accreditation reviews, and regulatory inspections, including preparation of documentation and follow-up activities
• Maintains document control processes, including creation, revision, distribution, retention, and archiving of controlled documents, forms, labels, and procedures
• Supports regulatory compliance activities by preparing, collecting, and maintaining records and documentation required for regulatory and accreditation requirements
• Assists with tracking quality events, deviations, corrective and preventive actions (CAPA), and other quality improvement initiatives
• Serves as a resource for donor advocacy activities, including responding to inquiries, maintaining records, and coordinating follow-up with appropriate departments
• Compiles, validates, and maintains quality-related data and assists in the preparation of reports, metrics, and trend analyses
• Coordinates with operational departments to support quality, compliance, and regulatory objectives and ensure timely resolution of documentation and recordkeeping needs
• Participates in process improvement initiatives and supports implementation of new procedures, systems, and quality programs

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