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.