Qureos Mentor

Paragon Laboratories

<div><div><b>Summary of Position:</b></div><div>
We are seeking an experienced and detail-oriented <b>Quality Assurance Regulatory Manager</b> to lead and strengthen our quality and compliance programs. In this role, you will be responsible for developing and implementing policies and procedures that ensure adherence to strict production quality standards. You will oversee audits of processes, materials, and finished products, while driving continuous improvement through analysis of quality trends, defects, and deviations.<br>
This position also plays a critical role in managing regulatory compliance by coordinating and documenting internal processes, including audits, inspections, license renewals, and registrations. The ideal candidate is proactive, highly organized, and passionate about maintaining excellence in quality and regulatory standards within a fast-paced environment.<br>
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Duties and Responsibilities:</b></div><ul><li>
Manage and review cGMP documentation including but not limited to Master Formulations, Batch Production and Packaging records, protocols, and deviations.</li><li>
Provide final disposition of materials and products.</li><li>
Oversee and maintain Food Safety, Food Defense and Standard Operating Procedures programs.</li><li>
Manage calibration, complaint, material review, change control and CAPA programs.</li><li>
Sanitation Supervisor.</li><li>
Assist in hosting regulatory inspections and audits performed by regulators, certifying agencies and customers.</li><li>
Maintain required regulatory permits and licenses.</li>
Other duties as assigned by management.<br>
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Supervisory Responsibilities:</b></div><ul><li>
Quality Assurance Supervisor.</li><li>
Quality Assurance Inspectors.</li><li>
Sanitation Department.</li>
Document Control.<br>
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Education Requirements</b></div><ul><li>
B.S. degree preferred in related field, or combination of certifications and experience.</li><li>
A minimum of 4 years as a Supervisor/Manager in a cGMP manufacturing environment.</li><li>
Knowledge of 21 CFR part 111.</li><li>
FSMA PCQI Certification.</li><li>
Knowledge of G.F.SI. Certifying bodies such as N.S.F., U.L., Organic Certifications, SQF, BRC, etc.</li>
Proficient in Microsoft Word &amp; Excel.<br>
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Physical Requirements:</b></div><ul><li>
Requires standing/walking 50% of the day, roughly 4 hours.</li><li>
Minimal lifting, no more than 20 kg.</li><li>
Sitting stationary roughly 20%&ndash;50% of the day, up to 5 hours, with focus on computer tasks.</li><li>
Some slight bending/maneuvering.</li></ul></div>

Quality Assurance Manager

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Paragon Laboratories

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Quality Assurance Manager