Quality Assurance Compliance Specialist

Activate Talent; Philippines; Sur place; PHP 600 000 - 900 000; Plein temps

Résumé du poste

Activate Talent, LLC is seeking a Quality Assurance & Compliance Specialist to advance QA and regulatory programs for our Shop. You will work with the QA Manager to ensure products, ingredients, and partners meet quality and regulatory standards.

The role includes coordinating quality activities, monitoring supplier compliance, supporting consumer complaint investigations, and conducting regulatory reviews of formulations, labeling, and marketing materials.

Qualifications

• Must have experience in quality assurance and regulatory compliance for food/beverage products.
• Knowledge of FDA regulations and current good manufacturing practices (cGMPs).
• Proficient in maintaining and reviewing QMS documentation and records.
• Experience with CAPA and deviation management processes.
• Ability to conduct supplier and co-manufacturer quality audits and assessments.
• Experience reviewing product labels and claims to ensure regulatory compliance (FDA/FTC).

Responsabilités

• Coordinate cross-functional communication on quality and regulatory matters among internal teams and external partners.
• Identify and communicate quality risks and support preventive and corrective actions.
• Support the QMS implementation, maintenance, and documentation control and record keeping.
• Manage consumer complaint investigations and ensure timely resolution.
• Assist with supplier/co-manufacturer qualification and ongoing monitoring.
• Stay updated on FDA regulations, guidance, and industry standards relevant to products.
• Review formulations, labeling, and claims for regulatory compliance and support product development.

Connaissances

Quality Assurance

Regulatory Compliance

FDA Regulations

cGMPs

QMS Documentation

CAPA & Deviations

Supplier Audits

Label Review

Description du poste

The Quality Assurance & Compliance Specialist supports the implementation, maintenance, and continuous improvement of our 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:

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.

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.

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.

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.

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.

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.

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.

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.

Must Haves:

• Experience in quality assurance and regulatory compliance in food/beverage
• Knowledge of FDA regulations and cGMPs
• QMS documentation
• CAPA and deviation management
• Supplier/co-manufacturer quality audits
• Product label and claims review (FDA/FTC)