Quality Assurance Manager

The Quality Assurance Manager will oversee the implementation and management of the Quality Management System (QMS) that ensures the facility and products we make adhere to FDA guidelines 21 CFR Part 111/117 for Dietary Supplements and internal/external Quality guidelines . The QA Manager is accountable for ensuring compliance with the Quality Management System and Food Safety Plans. This individual will utilize quality skills to help identify and lead continuous improvement initiatives, ensure the quality attributes of products are met, and guide the QA teams in their day-to-day functions.

This role monitors quality performance metrics and provides regular reporting to senior management. The QA Manager serves as the primary point of contact for second- and third-party audits and inspections, testing review and disposition, batch record approvals, and customer complaint investigations. The individual is required to follow cGMP (current Good Manufacturing Practices), all Standard Operating Procedures, and Food Safety Regulations.

• Management of contingency policy for product recall, as well as responsible for building and implementing IQ, OQ, and PQ systems for new installations.
• Manage the Quality Assurance (QA) department, ensuring compliance with GMP, FDA regulations (21 CFR), and industry standards.
• Oversee the development, implementation, and continuous improvement of the Quality Management System (QMS).
• Supervise review and approval of batch records, specifications, and test results for raw materials and finished products.
• Maintain complete documentation of quality activities, ensuring proper storage, accessibility, and regulatory compliance.
• Act as the primary contact for regulatory agencies and external auditors during inspections and audits.
• Lead quality initiatives, including process optimization, risk management, and continuous improvement projects to enhance product quality and operational efficiency.
• Train Production personnel on data integrity, documentation practices, hygiene, and gowning protocols.
• Work with suppliers to ensure the quality of ingredients.
• Ensure that that facility and operations comply with FDA, customer and certification standards and audits. (FSSAI,WHO-GMP, USFDA etc.)

• Create/edit SOPs, deviation reports, specifications, and other Quality Management System documents.
• Monitor regulatory changes and implement updates to quality systems and procedures
• Maintain mandated quality documentation, records, and traceability systems
• Ensure compliance with domestic and international food and dietary supplement laws and regulations.
• Ensure compliance as FSTL to quality management systems (BRC, ISO 22000, US FDA)
• Ensure compliance with quality standards, regulations, and guidelines. This includes following developments in legislation and requirements and translating them into the quality system. Adherence to 21 CFR and FDA guidance, NSF, Organic, Kosher, Halal and other relevant standards.
• Ensure that raw materials and finished products meet quality standards. This includes inspecting and testing products and production equipment and rejecting products that don't meet standards.
• Prepare overview of the process flow for warehouse and raw materials.
• Author, review and approve SOPs, specifications, batch records and quality agreements
• Review customer requirements and translate requirements into product and process specifications.
• Provide QA oversight of production and packaging operations, identify corrective actions.
• Review and approve batch records, lab data and release documentation
• Lead investigations and corrective/preventive actions and ensure compliant implementation.
• Identify opportunities for process and packing line processes to ensure adhere to QMS principles.
• Develop/monitor HACCP system.
• Schedule and manage external quality audits and supplier qualification.
• Ensure FDA guidelines and 21 CFR compliance for external audits.
• Ensure periodic plant and vendor audits, compliance and timely closure of non-conformities.
• Ensure periodic reviews on food safety objectives and process verification is executed.
• Ensure timely implementation of CAPA for internal/external deviations.
• Train and manage production line staff in quality assessment and production practices.
• Prepare reports on quality, food safety, and customer satisfaction. This includes collecting, analyzing, and summarizing data, and preparing graphs and charts.
• Collaborate with internal teams (Operations, Sales, Supply Chain, etc.) to ensure trial success and product readiness
• Train teams on best practices for SOPs, sensory expectations, and critical to quality parameters
• Monitor facility compliance with key manufacturing SOPs including testing protocols, sanitation practices, palletizing, and storage.

• Strong attention to detail and organizational skills.
• Critical thinking skills.
• Interpersonal and communication skills.
• Strong ability with numbers and data analysis skills.
• Technical skills and comfort…