This individual will be a part of a team which will implement, support and maintain pharmaceutical cGMP’s and the Quality Management System at the Madison site as needed to assure the compliance of products produced by DuPont with all internal, customer and regulatory requirements. Essential Duties and Responsibilities • Contribute to the review and assessment of Deviations, Management of Change, Corrective Actions, and Non-Conformances. • Participate in the review and approval of validation documentation. • Participate in customer, certification, and regulatory audits and following up on corrective actions, as needed. • Contribute to monitoring and trending of process performance for APR (Annual Product Review) and plant continuous improvement initiatives. • Assist with the creation and communication of new and changing procedures to the site under the established documentation control procedures and in compliance with certification standards and company guidelines. • Perform internal audits for the maintenance and continuous improvement of the management system and compliance to regulatory requirements. • Review and release of batch records (both production and QC) in compliance with various internal and external requirements.
Knowledge, Skills, and Abilities • Must have a Bachelor’s degree in Microbiology, Biology, Food Science, or related field or a minimum of 3 years of experience in Quality Assurance/Quality Control, cGMP’s, Food Safety or Regulatory Compliance. • Experience working in a GMP environment (i.e. ICH Q7, medical devices or dietary supplements). • Must be willing to participate and contribute to team-based problem-solving of manufacturing quality events and/or issues. • Experience with the following is desired but not required: Regulatory and/or customer audits Experience with CAPA (Corrective & Preventative Actions) systems Internal auditing Training presentations relevant to Management Systems