About the Job

Associate, Quality Assurance & Regulatory Affairs (QA/RA)

Location: New York Tri-State Area

About Cabinet Health:

Cabinet Health is a next-generation healthcare company revolutionizing the way medicine is sourced, packaged, and delivered. We partner with national retailers, wholesalers, and emerging brands to provide high-quality OTC and prescription products through a sustainable, transparent, and radically efficient supply chain.

Position Overview:

Cabinet Health is seeking a mission-aligned Associate, Quality Assurance & Regulatory Affairs to support the execution and maintenance of our Quality Management System (QMS) and regulatory compliance activities across our OTC, dietary supplement, and packaging portfolio. This role is hands-on and execution-focused, supporting day-to-day QA/RA operations, supplier oversight, documentation, and regulatory readiness under the direction of the Head of QA/RA.

The ideal candidate has 3–4 years of QA/RA experience, is detail-oriented, comfortable working within regulated environments, and is eager to grow into increased ownership and responsibility over time.

Reports To

Head of Quality Assurance & Regulatory Affairs

Key Responsibilities:

Quality Management System (QMS) Support

• Support the development, maintenance, and execution of SOPs and quality records in alignment with FDA and applicable ISO requirements
• Assist with document control activities, including version control, document routing, approvals, archival, and training assignments
• Support deviation, CAPA, change control, supplier management, and complaint management activities
• Assist with preparation and maintenance of inspection-ready documentation

Regulatory Affairs Support

• Support regulatory documentation activities related to OTC drugs, dietary supplements, and packaging (e.g., product listings, label reviews, supporting documentation)
• Assist with label review for compliance with FDA requirements and internal standards
• Support compilation of regulatory responses and documentation for retail partners and regulatory agencies as directed

Vendor Oversight

• Support supplier qualification, onboarding, and ongoing monitoring activities under established procedures
• Assist with review of supplier documentation, including Certificates of Analysis (CoAs), batch records, specifications, and quality agreements
• Support coordination of supplier audits (remote and on-site)
• Track and follow up on supplier CAPAs and corrective actions
• Work with third-party laboratories to arrange product testing

Stability, Testing & Product Quality Support

• Assist with coordination and tracking of stability studies, third-party testing, and lab documentation
• Support review of analytical data and reports for completeness and compliance
• Maintain organized records for stability, testing, and product quality documentation

Cross-Functional Collaboration

• Work closely with Operations team, and external partners to ensure quality requirements are integrated into day-to-day activities
• Support continuous improvement initiatives across quality processes and documentation

Qualifications:

Required

• Experience with OTC drugs, and/or dietary supplements, consumer care products
• Bachelor’s degree in Life Sciences, Engineering, Chemistry, or a related field
• 3+ years of experience in Quality Assurance, Regulatory Affairs, or Quality Systems within a regulated industry (pharmaceuticals, medical devices, combination products, or related field)
• Working knowledge of FDA regulations (e.g., 21 CFR 210/211, 201, 111)
• Experience supporting QMS elements such as SOPs, CAPAs, deviations, document control
• Strong attention to detail and ability to manage multiple tasks and timelines
• Clear written and verbal communication skills
• Working knowledge of AI tools (e.g., ChatGPT, Notion AI, Airtable AI) and a willingness to adopt emerging tech to enhance performance
• Strong communication skills and ability to manage both strategic discussions and tactical details with internal and external stakeholders
• Highly organized with a bias for action and a focus on delivering measurable results
• Comfortable working in ambiguity

Preferred

• Familiarity with USP and ICH standards and basic stability/testing concepts
• Experience working with third-party manufacturers, labs, or suppliers
• Experience working in a GMP regulated environment, and notified body audits
• Experience with packaging product development