Quality Assurance Specialist

Purpose
The Quality Assurance Specialist is responsible for ensuring compliance with all applicable regulatory,
accreditation, and internal quality system requirements. This role provides oversight of quality
documentation, and quality system processes to ensure the safety, quality and traceability of human
tissue. This role serves as a key quality influence supporting continuous improvement, audit readiness,
and protection of donor intent and recipient safety.

Responsibilities

• Review HCT/P donor records in accordance with standard operating procedures and regulatory
  requirements
• Review quality control records to include equipment cleaning/maintenance, environmental
  monitoring, and supply inspections
• Review HCT/P donor records for final product release in accordance with standard
  operating procedures and regulatory/accrediting agency requirements
• Inspect HCT/P products in accordance with standard operating procedures and regulatory
  requirements
• Sort and segregate acceptable and unacceptable HCT/P products
• Identify and initiate quality events
• Communicate and escalate inspection or quality control issues to Management when necessary
• Support internal/external audits recommended: Conduct internal audits; support FDA & AATB
  inspections
• Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB Standards, ISO
  Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational
  policies and standard operating procedures
• Maintain acceptable attendance and punctuality for scheduled work hours and meetings.
• Ensure completion of assigned tasks and responsibilities within defined timeframes
• Flexibility to work outside of normal business hours during weekdays or weekends with
  reasonable advance notice to support business/operational needs when necessary
• Perform other duties as assigned

Skills

• Ability to work independently and in a team environment
• Excellent attention to detail and organization
• Excellent written and verbal communication
• Highest level of ethics and integrity
• Ability to lead and motivate the right behaviors
• Ability to multi-task and work in a fast-paced environment
  
• Strong technical writing
• Effective project management
• Proficiency in Microsoft Office

Qualifications/Requirements

• Associate degree (or 60 hours from an accredited college or university) in a biological science,
  engineering, or related field required
• At least 0-2 years of experience in an FDA regulated environment for HCT/Ps, medical devices,
  pharmaceuticals, and/or related field preferred
• Bachelor's degree in biological science, engineering, or related field preferred
• 2 years of relevant work experience may be substituted for the degree requirement
• Valid Class C Driver's license
• Clearance of favorable background investigation required