Quality Assurance & Compliance Specialist

Quality Assurance & Compliance Specialist

The Loaded Tea Shop
Reports To: Quality Assurance Manager

Position Summary
The Quality Assurance & Compliance Specialist supports the implementation, maintenance, and continuous improvement of The Loaded Tea Shop's quality assurance and regulatory compliance programs. Working closely with the Quality Assurance Manager, the Specialist helps ensure that products, ingredients, manufacturing partners, and business operations meet established quality standards and applicable regulatory requirements.
The role is responsible for coordinating quality management activities, monitoring supplier and co-manufacturer compliance, supporting consumer complaint investigations, and conducting regulatory reviews of product formulations, labeling, and marketing materials. The Specialist collaborates with cross-functional teams and external partners to proactively identify risks, resolve quality concerns, and support the successful commercialization of safe, compliant, and high-quality products.

Key Responsibilities
1. Cross-Functional Communication & Collaboration
Facilitate effective communication and collaboration among internal departments, leadership teams, co-manufacturers, suppliers, and external stakeholders to support alignment on quality and compliance requirements.
Establish and maintain productive working relationships with cross-functional teams to facilitate timely resolution of quality and regulatory matters.
Communicate quality concerns, compliance risks, and regulatory updates to relevant stakeholders, escalating significant issues to the QA Manager as appropriate.

2. Quality Risk Management & Continuous Improvement
Proactively identify, assess, and communicate potential quality, food safety, regulatory, and consumer satisfaction risks, recommending appropriate preventive and corrective measures.
Monitor emerging regulatory requirements, industry developments, and compliance trends to identify potential impacts on products and business operations.
Support continuous improvement initiatives to strengthen quality systems, enhance operational efficiencies, and minimize compliance risks.

3. Quality Management Systems & Documentation
Support the implementation, maintenance, and continuous improvement of the company's Quality Management System (QMS), ensuring alignment with internal quality standards and applicable regulatory requirements.
Coordinate the preparation, review, maintenance, and retrieval of quality documentation, including standard operating procedures, product specifications, supplier qualification records, and compliance documentation.
Collect, analyze, and report quality performance data to monitor key performance indicators (KPIs), identify trends, and evaluate the effectiveness of quality assurance processes.
Assist with quality investigations, deviation management, corrective and preventive actions (CAPAs), and the verification of corrective action effectiveness.
Maintain accurate, complete, and readily accessible quality records to support internal reviews, external audits, and regulatory inspections.

4. Consumer Complaint Management
Coordinate the day-to-day administration of the consumer complaint management program, ensuring complaints are appropriately documented, assessed, investigated, and resolved in a timely manner.
Liaise with Customer Service, Operations, and co-manufacturing partners to facilitate complaint investigations, root cause analysis, and corrective action implementation.
Monitor and analyze complaint data to identify recurring issues, emerging product quality concerns, and opportunities for continuous improvement.
Escalate potentially significant product safety concerns, adverse events, and regulatory compliance issues to the QA Manager for further assessment and appropriate action.

5. Co-Manufacturer & Supplier Quality Compliance
Support the qualification, assessment, and ongoing monitoring of co-manufacturers, raw material suppliers, packaging suppliers, and other external business partners to ensure compliance with established quality and regulatory requirements.
Review supplier and manufacturing documentation, including Certificates of Analysis, technical specifications, food safety certifications, allergen declarations, and other relevant compliance records.
Monitor co-manufacturer compliance with applicable FDA regulations, Current Good Manufacturing Practices (cGMPs), food safety requirements, and established quality agreements.
Coordinate documentation and compliance activities associated with third-party certifications, including Kosher, Halal, Vegan, and applicable food safety certification programs.
Assist with supplier audits, compliance assessments, and the investigation and resolution of supplier-related quality concerns.
Support change control processes for ingredients, formulations, manufacturing processes, packaging materials, and supplier changes.

6. Regulatory Compliance & Intelligence
Maintain current knowledge of applicable FDA regulations, regulatory guidance, industry standards, and emerging regulatory developments relevant to the company's product portfolio.
Monitor and assess regulatory changes, communicating potential compliance implications and recommended actions to the QA Manager and relevant stakeholders.
Conduct preliminary regulatory due diligence and compliance assessments for existing and prospective suppliers, co-manufacturers, and business partnerships.
Support the evaluation of ingredient regulatory status, product classification, and applicable regulatory requirements for new and existing products.

7. Product Formulation, Labeling & Claims Review
Conduct regulatory reviews of product formulations, ingredients, and technical specifications to assess compliance with applicable food safety and regulatory requirements.
Review product labels, Nutrition Facts panels, ingredient declarations, allergen statements, precautionary warnings, and other mandatory labeling elements for regulatory compliance.
Evaluate product claims and consumer-facing materials, including packaging, website content, advertising, and promotional assets, to support compliance with applicable FDA and FTC requirements.
Collaborate with R&D, Marketing, and Operations to identify and address regulatory considerations throughout product development, reformulation, and commercialization.
Maintain accurate records of regulatory assessments, labeling reviews, and compliance recommendations.

8. Product Certifications & International Compliance
Support the preparation, submission, and maintenance of documentation required for third-party product certifications, government registrations, and applicable regulatory approvals.
Assist with regulatory assessments for international market expansion, including product classification, ingredient permissibility, formulation compliance, labeling, and claims requirements.
Prepare and coordinate technical documentation, product registration dossiers, Letters of Authorization, Certificates of Free Sale, Export Certificates, and other applicable regulatory documents.
Liaise with external consultants, certification bodies, and regulatory authorities to facilitate documentation requests and support ongoing compliance activities.

Skills

Experience in quality assurance and regulatory compliance in food/beverage; knowledge of FDA regulations and cGMPs; QMS documentation, CAPA and deviation management; consumer complaint handling; supplier/co-manufacturer quality audits; product label and claims review (FDA/FTC); strong cross-functional communication.

Experience with Kosher, Halal and Vegan certifications; international regulatory documentation (Certificates of Free Sale, Export Certificates, product registration dossiers).