NCR Writer Round Lake, IL

Job Description

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission.

As a Manufacturing Technical Writer, you will play a pivotal role in ensuring our operations adhere to the highest standards of quality and compliance. This is where your expertise will drive flawless execution of regulatory requirements and contribute to our world-class manufacturing processes. Your success in this role will be measured by your ability to effectively manage non-conformance investigations and implement corrective actions that maintain our outstanding standards.

Our team is dedicated to Baxter's mission of saving and sustaining lives. We cultivate a collaborative culture where we support each other to achieve ambitious goals. Baxter values its employees, offering benefits such as volunteer days, support for working parents, and matching contributions to your retirement plan.

• Perform non-conformance (NCR) investigations within the Track Wise 8 Management System.
• Complete implementation of CAPAs associated with NCR investigations.
• Maintain a high level of expertise in current regulatory requirements.
• Serve as a plant resource for compliance and maintain audit-ready status.
• Provide mentorship on DMAIC problem-solving and process improvement projects.
• Ensure compliance with local procedures, US & International Regulatory, and Baxter corporate quality requirements.

• BS/BA in science, engineering, or related field.
• 2-4 years of relevant work experience in a cGMP-related industry or clinical setting.
• The candidate must not be allergic to penicillin or cephalosporin drugs
• Strong problem-solving and analytical skills.
• Excellent written/verbal communication and organizational skills.
• Ability to make independent decisions with minimum oversight.
• Greenbelt certification or equivalent experience using Six Sigma or other Lean Manufacturing tools.
• Experienced user of Track Wise.
• Working knowledge of FDA Regulations and International Regulatory requirements.
• Understanding of risk management tools.
• Available to work during off-shift or weekends as needed.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $64,000 - $88,000 annually. The estimated range is meant to reflect an anticipated salary range for the position.

We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance.…