Quality Assurance Specialist
| Position Title: | Quality Assurance Specialist |
| Department: | Quality Assurance |
| Reports To: | Quality Assurance Manager |
| Job Type: | Full Time |
| Shift: | Monday - Friday 08:30 AM - 05:00 PM |
| Exempt / Non-Exempt: | Non Exempt |
Purpose:
The Quality Assurance Specialist is responsible for ensuring that all products and quality control processes meet established quality requirements.
Duties & Responsibilities:
- Inspect HCT/P products in accordance with standard operating procedures and regulatory requirements.
- Sort and segregate acceptable and unacceptable HCT/P products.
- Prepare shipping documents and packages in accordance with standard operating procedures based on order requests.
- Communicate and escalate inspection or quality control issues to Management/Quality Assurance as necessary.
- Review quality control records to include equipment cleaning/maintenance, environmental monitoring, and supply inspections.
- Assist with reviewing HCT/P donor records in accordance with standard operating procedures and regulatory requirements.
- Assist in routing, editing, and finalizing controlled documents, ensuring consistency and compliance to formatting and template requirements.
- Initiate, review, and investigate quality events.
- Support and/or perform internal and external audits.
- File and maintain records in accordance with standard operating procedures.
- Maintain working knowledge of regulatory requirements.
- Perform other related duties as assigned.
Skills & Abilities:
- Excellent attention to detail and organization skills
- Self-motivated
- Ability to work in a fast-paced environment.
- Effective verbal and written communication skills.
Education & Experience:
- Associate degree (or 60 hours from an accredited college or university) in a biological science or related field required.
- Bachelor`s degree in a biological science or related field preferred.
- 1 year of experience in an FDA regulated environment for HCT/Ps and/or medical devices preferred.