As part of our Nutrition and Biosciences division, this individual will monitor and support the Quality Management System at their Madison site and other Food Safety and Quality Programs as needed to assure the compliance of products with all internal, customer, and regulatory requirements.
This position reports directly to the QA & Food Safety Manager for the Madison site and is directly responsible for the maintenance and verification of Quality Management Systems at the Madison site.
• Provide leadership, coordination, insight and individual contribution in obtaining and maintaining Pharmaceutical API compliance
• Verification of batch records in compliance with various standards including: Dietary Supplements (21CFR111) and ICH Q7 API Active Pharmaceutical Ingredients.
• Participate in customer, certification, and regulatory audits, and contributing to completing pre-audit questionnaires, and following up on corrective actions, as needed.
• Contribute to effective management of Deviations, Corrective Actions, and Non-Conformances
• Contribute to monitoring and trending of process performance
• Coordinate documentation control and contribute to ensuring quality procedures are up-to-date, complete and properly followed, and coordinate any modifications in compliance with certification standards and company guidelines.
• Organize quality and food safety training, internal audits, quality meetings, etc
• 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.