Quality Assurance Specialist

Purpose

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

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

· 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

· Bachelor’s degree in a biological science, engineering, or related field preferred

· At least 0-2 years of experience in an FDA regulated environment for HCT/Ps, medical devices, pharmaceuticals, and/or related field preferred

· Additional relevant work experience may be substituted for the degree requirement on a year-for-year basis

· Clearance of favorable background investigation required