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.