Quality Assurance & Quality Control (QA/QC) Specialist

Position Summary

The Quality Assurance & Quality Control (QA/QC) Specialist is responsible for ensuring all products consistently meet company quality standards, regulatory requirements, retailer compliance expectations, and customer satisfaction goals. This role oversees both Quality Assurance and Quality Control functions across Consumer Packaged Goods (CPG), Medical Devices, Over-the-Counter (OTC) products, and Cosmetics.

The QA/QC Specialist serves as the primary quality and regulatory resource, partnering with internal teams, suppliers, manufacturers, third-party laboratories, inspection agencies, and retail customers to maintain compliance, improve product quality, and support successful product launches. This position requires a proactive professional with strong knowledge of FDA regulations, GMP, supplier quality management, inspections, auditing, and continuous improvement.

Key Responsibilities

1. Quality Assurance & Regulatory Compliance

• Ensure compliance with all applicable local, state, and federal regulations governing Consumer Packaged Goods (CPG), Medical Devices, OTC products, and Cosmetics.

• Review and verify product formulations, ingredients, packaging, labeling, and marketing claims for compliance with FDA regulations and applicable industry standards.

• Monitor changes to regulatory requirements and implement updates to quality systems, procedures, and documentation.

• Support FDA product registrations, regulatory submissions, retailer compliance requests, and customer audits.

• Coordinate third-party laboratory testing and evaluate test reports to ensure compliance with product specifications and regulatory requirements.

• Develop, maintain, and continuously improve Quality Management System (QMS) documentation, policies, procedures, and work instructions.

• Lead investigations into quality issues and implement effective Corrective and Preventive Actions (CAPA).

• Train employees on quality standards, regulatory requirements, inspection procedures, and documentation best practices.

2. Quality Control & Supplier Quality Management

• Conduct supplier qualification, onboarding, and ongoing supplier performance evaluations.

• Coordinate and oversee supplier GMP audits, social compliance audits, and quality assessments.

• Review inspection reports from manufacturing partners, internal quality teams, and third-party inspection agencies.

• Coordinate pre-production, in-process, and final product inspections to verify compliance with quality standards and specifications.

• Evaluate product samples for functionality, safety, workmanship, packaging, labeling accuracy, and overall product quality.

• Collaborate with suppliers and manufacturers to resolve quality issues and implement continuous improvement initiatives.

• Manage relationships with third-party inspection agencies and laboratory service providers.

3. Product Quality & Continuous Improvement

• Support new product development and product launch activities by establishing quality requirements and compliance expectations.

• Collaborate with Product Development, Operations, Purchasing, Sales, Customer Service, Suppliers, Manufacturers, and third-party laboratories to ensure successful product launches.

• Investigate customer complaints related to product quality, packaging, defects, safety, and performance.

• Perform root cause analysis and implement Corrective and Preventive Actions (CAPA) to prevent recurring issues.

• Analyze inspection results, audit findings, supplier performance, and customer feedback to identify trends and drive continuous improvement.

• Recommend and implement process improvements that enhance product quality, supplier performance, and customer satisfaction.

4. Documentation, Audits & Project Management

• Prepare, review, and maintain regulatory and quality documentation for private-label and controlled-brand products.

• Maintain organized records of supplier qualifications, audit reports, inspection reports, laboratory testing, CAPA records, complaint investigations, and regulatory submissions.

• Ensure documentation is accurate, complete, and audit-ready.

• Manage quality and compliance timelines for new product launches and ongoing product programs.

• Identify project risks and implement proactive solutions to prevent delays or compliance issues.

• Provide regular qualit