Associate II, Quality (3-11pm)

Responsibilities

• Serve as an SME for trending, Management Review, local and corporate metrics, APQR, and other systems involving metrics.
• Complete trending, APQR, and Management review process objectives.
• Utilize knowledge of software to compile and interpret data, and work with statistical and trending software to analyze data.
• Ensure compliance with all applicable SME-related Standard Operating Procedures (SOPs).
• Participate in FDA inspections, preparing materials and interfacing directly with FDA.
• Ensure audit readiness of the area by researching background information, maintaining current and in alignment with procedures, and reviewing related audit results.
• Remain current in industry and regulatory trends in this SME area through attendance at related conferences, seminars, meetings, and other training methods.
• Participate in the development and delivery of GxP training programs, as needed.
• Work closely with production supervisors, quality, engineering, and other internal groups to accomplish the above and influence necessary actions.
• Write, review, analyze, and revise written Standard Operating Procedures (SOPs) to meet regulatory, corporate, and plant requirements.
• Support and participate with management during external inspections, as needed.
• Maintain a clean and safe work area using 6S principles.
• Perform other duties, tasks, or projects, as assigned.

Requirements

• High School Diploma, GED, or equivalent required. Must be at least 18 years of age.
• BS in engineering/science or equivalent work experience.
• Multiple years of experience in Quality with a medical device/Pharma company or other similarly regulated industry.
• Strong interpersonal skills and great attention to detail are necessary.
• Must be a strong team player with good problem solving, and good verbal and written communication skills.
• Must have the ability to manage people, encourage teamwork and drive decisions.
• Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
• Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings.
• Must have basic English written and oral communication skills adequate to communicate with other team members.
• Other Duties as Assigned
• We understand compensation is an important factor as you consider the

Benefits

Additional Information

This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job-you will find purpose and pride. This is where your creativity addresses challenges We are seeking a Quality Associate II to serve as a Subject Matter Expert (SME) for trending, Management Review, local and corporate metrics, APQR, and other systems involving metrics. The ideal candidate will ensure compliance with all applicable processes, systems, and provisions of the Quality System in these areas, identify and resolve possible regulatory and quality risks, and provide Quality support and oversight of areas that input information into these systems. Your Team at Baxter Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation. The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always. What we offer from Day One Medical, Dental and Vision coverage 160 hours of Paid Time Off and Paid Holidays 401K match Employee Stock Purchase Program Paid Parental Leave Tuition Reimbursement

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