Your Role At BaxterThe Quality Associate III (Quality Engineer) is a key individual contributor responsible for driving quality engineering initiatives and supporting regulatory compliance within a pharmaceutical manufacturing environment. This role leads validation efforts and quality improvement projects, with a strong focus on enhancing and modernizing visual inspection programs for sterile products. The position partners cross-functionally to implement process improvements and ensure compliance to quality standards.
This role plays a critical part in advancing product quality and supporting key regulatory and operational priorities.What You'll Be DoingLead 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 problem 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 / regulationsLead audit ready status efforts for assigned areas and assist other areas within the facility in understanding FDA, ISO and Baxter quality requirements. Maintain a high level of expertise in current regulatory 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.What You'll BringBachelor's degree in Science or Engineering required5 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. Must be able to clearly document audit findings within audit reports.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