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


• 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


• Sort and segregate acceptable and unacceptable HCT/P


• 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.