Qureos Mentor

Threshold Enterprises

<div>Summary of Job Duties:
The Quality Assurance Compliance Specialist plays a key role in maintaining and improving the company&rsquo;s Quality Management System (QMS) and ensuring ongoing compliance with regulatory requirements, including 21 CFR 111, internal quality policies, FDA expectations, and external UL GMP certification standards. This position supports cross‑functional teams, contributes to continuous improvement initiatives, and helps uphold the company&rsquo;s commitment to product quality, safety, and regulatory integrity.
Specific Job Duties:<ul><li>
Support Customer Service, complaint handling activities by managing complaint intake, maintaining the complaint log, and conducting thorough adverse event reviews, investigations, and documentation. Generate and track CAPAs as needed.</li><li>
Work closely with R&amp;D to perform detailed label reviews, formulation overage updates ensuring alignment with MMR and FDA regulations, industry standards, and internal policies.</li><li>
Work closely with Purchasing to carry out Foreign Supplier Verification (FSVP) verification activities, including supplier documentation review, compliance HACCP assessments, and ongoing monitoring to ensure adherence to FDA requirements</li><li>
Assist with HACCP development and ongoing program maintenance, including hazard analysis updates, documentation control, verification activities, training and continuous improvement of food safety processes</li><li>
Assist during FDA inspections by coordinating timely record retrieval, supporting investigator requests, and contributing to the effective closure of any FDA observations.</li><li>
Develop, track, and report quality and compliance metrics as assigned by the Compliance Supervisor.</li><li>
Support annual UL GMP certification activities, including preparation, documentation, and audit readiness.</li><li>
Conduct internal compliance audits and follow up on corrective and preventive actions.</li><li>
Develop compliance training content and deliver companywide training on GMP, process improvements, and quality system requirements.</li><li>
Actively participate in QMS processes including SOP creating, Internal Audits, CAPA, Calibration, Training, and Document Control.</li><li>
Work with Production and QC teams to identify, correct, and prevent compliance‑impacting deficiencies.</li><li>
Analyze quality data, identify trends, and support implementation of effective corrective actions.</li><li>
Serve as a team member, project lead, or project manager on company initiatives related to quality and compliance.</li><li>
Perform other responsibilities as assigned by management.</li></ul>
Minimum Qualifications Required:<ul><li>
Associates Degree preferred</li><li>
2 years in QA/QC experience in an ISO or GMP environment</li><li>
Strong attention to detail, excellent writing (technical/investigation) and verbal communication skills.</li><li>
Excellent computer skills and working knowledge of Excel, Word and Outlook Email.</li></ul>
Skills and/or Training Desired:<ul><li>
Food Safety</li><li>
HACCP</li><li>
Excel
</li><li>Project Management</li><li>
QMS leadership; CAPA, Internal Audit, Training, Document Control</li><li>
Knowledge of Food Science, Chemistry or related fields</li><li>
Familiarity with FDA 21 CFR 111 a plus.</li><li>
Excellent communication skills both written and verbal.</li><li>
QA experience in a nutraceutical or pharmaceutical environment helpful but not required.</li><li>
QA experience in a food production facility a plus</li><li>
Training, presentation and Power Point experience.
</li><li>Ability to speak, read and write Spanish a plus, but not required.</li><li>
Internal auditing</li><li>
Experience with running a CAPA program</li><li>
Excellent collaborator, facilitator a big plus.</li></ul></div>

Quality Assurance FDA Specialist

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Threshold Enterprises

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Quality Assurance FDA Specialist