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Supv, Quality

Baxter International Inc.
Los Angeles, CA, 90001, USA

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Baxter International Inc. develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.Handle multiple projects. Demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, problem solving and team leadership. Lead Quality Work Teams (QWT), Kaizen or equivalent focus type group activities as required. A functional understanding of FDA, ISO and Baxter Quality systems is also required.1. Lead ongoing daily departmental activities for areas of direct responsibility (Aseptic Filling and Packaging) including supervision of assigned personnel, and when required assist other Quality areas in the successful performance of these activities.2. Manage activities of self and direct reports in achieving defined safety, quality, and production goals in an efficient, accurate and timely manner.3. Be directly involved in and where appropriate lead multiple process/product improvement projects which may include any of the following -QWT, Kaizen, Lean/5S, deploying Standard Work principles and/or other focus groups, validations, development of new methodologies and improving existing methodologies, data generation, report development and presentation.4. Lead in-plant audit ready status efforts for assigned areas and assist other areas within the facility in understanding FDA and Good Aseptic Practices, ISO and Baxter quality requirements. Knowledge of current regulatory requirements, and serve as a shift resource for compliance to these requirements.5. Lead in the development of customer awareness and understanding activities for areas of direct responsibility, and where appropriate, assist and support such activities throughout the facility.6. Provide guidance and coaching for the areas of responsibility as defined in items # 1 through #5 for less experienced individuals within the plant.7. Must have the ability to perform the assigned responsibilities of the Quality Management Inspection Manager on an as needed basis.Provides ongoing feedback related to quality issues.? Good interpersonal/communication/influencing/negation skills.? Good project management skills.? Working knowledge of FDA Regulations, Aseptic Processing Guidance, and Application of Good Manufacturing Practices.? Bachelor's degree in science or engineering.? Experience in Aseptic Processing, Visual Inspection, Packaging and Labeling operations is preferred.? Experience in auditing techniques, interpreting regulations and quality systems.? Minimum of 3-5 years of experience in Quality, or related field in the medical products industry.? Must be able to lift, push, pull and carry up to 25 lbs.? In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.? Must be able to work in controlled environments requiring aseptic gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body. ? No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the work environment. ? Could be working in a loud area that requires hearing protection and other protective equipment to be worn.? Ma

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