QA Pharma Compliance Specialist – Nutrition and Health

Job Listing No: 9740000

QA Pharma Compliance Specialist – Nutrition and Health

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. This position reports directly to the QA Manufacturing Lead – Pharma Project Manager for the Madison site and is directly responsible for the implementation and maintenance of the Management Systems at the Madison site. ESSENTIAL DUTIES AND RESPONSIBILITIES
The essential functions of this position include, but are not limited to, the following:
Provide leadership, coordination, insight and individual contribution in obtaining and maintaining Pharmaceutical API compliance.Act as the primary backup to the QA Pharma Compliance Lead.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.Review and assess Out-Of-Tolerance (OOT) reports in regards to product quality.Organize and perform quality training (i.e. GMP, GDP) for plant personnel.Coordinate systems between Corporate Q&FS and the site.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.This position operates in both the office and plant environments. Qualifications: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 possess effective communication, interpersonal, team-building skills at various levels with other departments.  Must be comfortable speaking in front of large groups.Must possess strong organizational and time-management skills and the ability to work independently.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 auditsExperience with CAPA (Corrective & Preventative Actions) systemsInternal auditingTraining presentations relevant to Management Systems

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