What are the responsibilities and job description for the Quality Assurance Specialist position at Extremity Care?
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.
