QA&FS Specialist – Dietary Supplements
NATURE OF WORK To monitor and support the Quality Management System at the Madison site and other Food Safety and Quality Programs as needed to assure the compliance of products produced by or for DuPont with all internal, customer, and regulatory requirements. ESSENTIAL DUTIES AND RESPONSIBILITIES The essential functions of this position include, but are not limited to, the following: Provide leadership and individual contribution in maintaining compliance with regulations for Dietary Supplements and Food Ingredients, quality certifications, and customer expectations. Contribute to ensuring quality procedures are appropriate and properly followed and coordinate procedural improvements as assigned. Provide leadership and individual contribution in the development of procedures for new initiatives and standards, as needed, such as TGA and Q7A API Active Pharmaceutical Ingredients. Daily verification and release of batch records in compliance with various internal and external standards, including finished formats. Organize and deliver quality training, including GMPs, GDPs, Pre-Requisite Programs, and other quality procedures Contribute to management, investigating, and resolution of Deviations, Corrective Actions, and Non-Conformances Contribute to administration of Change Management Contribute to monitoring and trending of process performance in quality programs Coordinate or participate in documentation control Perform internal audits for GMPs, Pre-requisite Programs, ISO 9001, and FSSC 22000 Participate in customer, certification, and regulatory audits, contribute to completing pre-audit questionnaire, and contribute to resolution and closure of corrective actions. Support the site???s food safety management system, including verification of HACCP and PRPs, and validation of processes and equipment. Communicate internally any information concerning GMPs, quality, and food safety. Ensure adherence to DuPont???s Quality and Environmental Policies and Procedures. Comply with all company policies, including maintaining a drug free work place. Support an environment of continuous improvement within the assigned area and develop awareness for product and production quality. Interact at various levels with other departments and regulatory agencies.DuPont is an Equal Opportunity EmployerDuPont is an e-Verify Employer *LI-AB1Qualifications:KNOWLEDGE, SKILLS AND ABILITIES Must have a Bachelor???s degree in Microbiology, Biology, Food Science, or related field, and/or a minimum of 3 years??? experience in Quality Assurance or Quality Control, cGMPs, Food Safety, and Regulatory Compliance Experience with regulatory compliance of products regulated under FDA 21CFR111 (dietary supplements), preferred. Experience with manufacturing of dietary supplements, excipients, pharmaceuticals, or medical devices, a plus. Experience with FDA Q7A GMPs for API and Australian TGA, a plus. Experience working with operations in a related manufacturing environment, highly preferred, including pre-operational inspections, environmental monitoring, and compliance monitoring and trending. Experience with regulatory and customer audits preferred. Experience with CAPA (Corrective & Preventative Actions) systems, preferred. Experience working in an ISO-certified and/or GFSI (SQF or FSSC 22000) ???certified environment, a plus. HACCP certification and working knowledge of HACCP food safety programs preferred. Experience with validation of processes and CCPs, a plus. Experience with training presentations relevant to regulatory compliance, GMPs, Food Safety, HACCP, etc, preferred. Trained in Internal Auditing, a plus.Apply for this job.