Overview
Quality Assurance Specialist Jobs in San Antonio, Texas, USA 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 requirements
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 HCP/P products in accordance with standard operating procedures and regulatory requirements
Sort and segregate acceptable and unacceptable HCT/P products
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 time frames
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 requirment on a year-for-year basis
Clearance of favorable background investigation required
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Title: Quality Assurance Specialist
Company: Extremity Care
Location: San Antonio, Texas, USA
Category: Quality Assurance – QA/QC, Healthcare (Data Scientist)
