Determine scope, product impact, root cause and corrective actions for deviations from manufacturing procedures. Determine appropriate preventive actions to avoid reoccurrence of the deviation.
Every day, Baxter touches the lives of millions of patients and providers worldwide who rely on our essential hospital and renal products and services. You'll find Baxter's products and therapies on nearly every floor, in almost every hospital worldwide, in clinics and in the home. Baxter's employees are building upon the company's rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care. Our commitment to our mission means we are there when patients and healthcare professionals need us, during the critical moments that matter most.
Scope: The deviation owner leads the investigation of deviations that occur in operations and is responsible for authoring the investigation summary report. Partners with Quality, Operations, Engineering, Maintenance, and Supply Chain to ensure appropriate and timely determination of scope, product impact, root cause and corrective and preventive actions. Interacts will all levels of staff and provides status updates as well as present the strategy for closure of deviations. Manage several investigations at a time.
Conduct personnel interviews to determine root cause of the deviation.
Foster collaborative relationships focused on high quality investigations, meaningful corrective actions and the reduction of deviation generation rate.
Set up and run meetings with cross functional teams.
Close deviations in a timely manner to meet business and compliance needs.
Work with minimal supervision to drive deviations to closure.
Work with Subject Matter Experts and Quality Approvers to determine the breadth and scope of the investigation to identify the appropriate root cause, implement corrective and preventive actions, complete trending analysis, and recommend product disposition.
Present and defend investigations during regulatory inspections, as required.
Strong communication and project management skills. Must have a thorough understanding of pharmaceutical manufacturing process and equipment, preferably parenteral solutions, and current Good Manufacturing Practices (cGMPs). Must have good analysis, troubleshooting, and investigation skills. Must be able to put complex thoughts and issues into writing in such a manner than an educated, but uninformed reader can understand and make decisions based on the written investigation report. Must be able to interact with, and influence others at various levels in multiple departments.
Education: Bachelor's degree in science or engineering; advanced degree in the life sciences, physical sciences or engineering, with 2-3 years of experience in root cause evalaution, interpreting regulations and quality systems. Minimum of 5-8 years of experience in Manufacturing Operations and or Quality, or related field in the medical products industry.
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an email to Corporate_Staffing_Deerfield@baxter.com or call 877-229-4748 (877-BaxHR4U) and let us know the nature of your request along with your contact information.
A little about us:
Our employees are connected by an enduring commitment to save and sustain lives. This higher purpose binds us in doing work that matters.