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.
