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This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.
Job Responsibility
Lead ongoing daily departmental activities for areas of direct responsibility and assist other Quality areas in the successful performance of these activities
Drive root cause problem solving for non-conformances in area of responsibility, and champion problems solving on the manufacturing floor
Lead multiple process/product improvement projects, design of experiments, validations, development of new methodologies and improving existing methodologies, data generation, report development and presentation
Manage activities in achieving defined quality goals in an efficient, accurate and timely manner
Ensure business needs and timeliness requirements of the department are met or exceeded
Write, review, analyze and revise written Procedures and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc
Partners with other functions, facilities, divisions, and regions to ensure successful implementation and compliance to procedures / regulations
Lead audit ready status efforts for assigned areas and assist other areas within the facility in understanding FDA, ISO and Baxter quality requirements
Demonstrate leadership ability and be recognized by all levels of the facility as a subject matter expert in their area
Assists and writes validations, audits and assessments
Requirements
Bachelor's degree in Science or Engineering required
5 or more years experience in IT, Engineering, Science or related field
Working knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices
Strong technical writing skills
Strong technical, analytical and problem solving skills
Good interpersonal, communication, influencing, negotiation skills
Understand scientific strategies and be able to invent new methods or new avenues of investigation
Good project management skills
What we offer
Medical and dental coverage
Basic life, accident, short-term and long-term disability, and business travel accident insurance