Quality Assurance Specialist

Purpose:

The Quality Assurance Specialist is responsible for ensuring that all products and quality control processes meet established quality requirements.

Duties & Responsibilities:

• Inspect HCT/P products in accordance with standard operating procedures and regulatory requirements.
• Sort and segregate acceptable and unacceptable HCT/P products.
• Prepare shipping documents and packages in accordance with standard operating procedures based on order requests.
• Communicate and escalate inspection or quality control issues to Management/Quality Assurance as necessary.
• Review quality control records to include equipment cleaning/maintenance, environmental monitoring, and supply inspections.
• Assist with review HCT/P donor records in accordance with standard operating procedures and regulatory requirements.
• Assist in routing, editing, and finalizing controlled documents, ensuring consistency and compliance to formatting and template requirements.
• Initiate, review, and investigate quality events.
• Support and/or perform internal and external audits.
• File and maintain records in accordance with standard operating procedures.
• Maintain working knowledge of regulatory requirements.
• Perform other related duties as assigned.

Skills & Abilities:

• Excellent attention to detail
• Organized
• Self-motivated
• Ability to work in fast paced environment
• Effective verbal and written communication

Education:

Associate degree (or 60 hours from an accredited college or university) in a biological science or related field required.

Prefer Bachelor’s degree in a biological science or related field.

Experience:

Prefer at least 1 year of experience in an FDA regulated environment for HCT/Ps and/or medical devices (or related field).