Quality Assurance Specialist

<p>Purpose</p>

<p>The Quality Assurance Specialist is responsible for ensuring all products and quality control processes meet established quality requirements.</p>

<p>&nbsp;</p>

<p>Responsibilities</p>

<ul>

<li>Review quality control records to include equipment cleaning/maintenance, environmental monitoring, and supply inspections.<br></li>

<li>Inspect HCT/P products in accordance with standard operating procedures and regulatory</li>

<li>Sort and segregate acceptable and unacceptable HCT/P</li>

<li>Identify and initiate quality events.</li>

<li>Communicate and escalate inspection or quality control issues to Management when necessary.</li>

<li>Support internal/external audits.</li>

<li>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.</li>

<li>Maintain acceptable attendance and punctuality for scheduled work hours and meetings. Ensure completion of assigned tasks and responsibilities within defined timeframes.</li>

<li>Flexibility to work outside of normal business hours during weekdays or weekends with reasonable advance notice to support business/operational needs when necessary.</li>

<li>Perform other duties as assigned.</li>

</ul>

<p>&nbsp;</p>

<p>Skills</p>

<ul>

<li>Ability to work independently and in a team environment.</li>

<li>Excellent attention to detail and organization.</li>

<li>Excellent written and verbal communication.</li>

<li>Highest level of ethics and integrity.</li>

<li>Ability to lead and motivate the right behaviors.</li>

<li>Ability to multi-task and work in a fast-paced environment.</li>

<li>Strong technical writing.</li>

<li>Effective project management.</li>

<li>Proficiency in Microsoft Office.</li>

</ul>

<p><br></p>

<p>Qualifications/Requirements</p>

<ul>

<li>Associate degree (or 60 hours from an accredited college or university) in a biological science, engineering, or related field required.</li>

<li>Bachelor’s degree in a biological science, engineering, or related field preferred.</li>

<li>At least 0-2 years of experience in an FDA regulated environment for HCT/Ps, medical devices, pharmaceuticals, and/or related field preferred.</li>

<li>Additional relevant work experience may be substituted for the degree requirement on a year-for-year basis.</li>

<li>Clearance of favorable background investigation required.</li>

</ul>