📌 Core Information
🔹 Job Title: NCR Writer
🔹 Company: Baxter International Inc.
🔹 Location: Round Lake Beach, Illinois, United States
🔹 Job Type: Full-Time
🔹 Category: Manufacturing
🔹 Date Posted: July 3, 2025
🔹 Experience Level: 2-5 years
🔹 Remote Status: On-site
🚀 Job Overview
Key aspects of this role include:
- Ensuring adherence to regulatory requirements and quality standards
- Investigating non-conformances and implementing corrective actions
- Serving as a plant resource for compliance and maintaining audit-ready status
- Mentoring and supporting process improvement projects
ASSUMPTION: This role requires a high level of attention to detail, strong problem-solving skills, and the ability to work independently.
📋 Key Responsibilities
✅ 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 and mentorship on DMAIC problem-solving and process improvement projects
✅ Ensure compliance with local procedures, US & International Regulatory, and Baxter corporate quality requirements
ASSUMPTION: This role may require working off-shift or weekends as needed to ensure timely completion of investigations and corrective actions.
🎯 Required Qualifications
Education: BS/BA in science, engineering, or related field
Experience: 2-4 years of relevant work experience in a cGMP-related industry or clinical setting
Required Skills:
- 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 TrackWise
- Working knowledge of FDA Regulations and International Regulatory requirements
- Understanding of risk management tools
Preferred Skills:
- Experience in a pharmaceutical or medical device manufacturing environment
ASSUMPTION: While not explicitly stated, having a background in a regulated industry or environment would be beneficial for this role.
💰 Compensation & Benefits
Salary Range: $64,000 - $88,000 annually
Benefits:
- Medical Coverage
- Dental Coverage
- Life Insurance
- Accident Insurance
- Short-term Disability
- Long-term Disability
- Business Travel Accident Insurance
- Employee Stock Purchase Plan
- 401(k) Retirement Savings Plan
- Flexible Spending Accounts
- Educational Assistance Programs
- Paid Holidays
- Paid Time Off
- Family and Medical Leaves of Absence
- Paid Parental Leave
- Commuting Benefits
- Employee Discount Program
- Employee Assistance Program
- Childcare Benefits
Working Hours: 40 hours per week, with potential for off-shift or weekend work as needed
ASSUMPTION: The salary range provided is an estimate based on market data and may vary depending on factors such as location, skills, and experience.
📌 Applicant Insights
🔍 Company Context
Industry: Medical Equipment Manufacturing
Company Size: 10,001+ employees (Large enterprise)
Founded: 1931
Company Description:
- Baxter provides a broad portfolio of essential healthcare products and therapies, including medical devices, pharmaceuticals, and biotechnology products
- The company operates in over 100 countries and has a strong commitment to innovation, quality, and patient care
- Baxter's mission is to save and sustain lives, working alongside clinicians and providers around the world
Company Specialties:
- Medical Devices
- Biosurgery
- Anesthetics
- Pharmacy Automation
Company Website: http://www.baxter.com
ASSUMPTION: Working at Baxter offers opportunities to make a significant impact on patients' lives and contribute to the company's mission of saving and sustaining lives.
📊 Role Analysis
Career Level: Mid-level professional with opportunities for growth and development
Reporting Structure: This role may report to the Quality Manager or a similar position within the manufacturing department
Work Arrangement: On-site, with potential for off-shift or weekend work as needed
Growth Opportunities:
- Advancement to senior or management roles within the quality department
- Transition to other roles within Baxter's manufacturing or operations divisions
- Expansion of skills and knowledge through training and development opportunities
ASSUMPTION: This role offers opportunities for professional growth and development, as well as the chance to work in a dynamic and challenging environment.
🌍 Location & Work Environment
Office Type: Manufacturing facility
Office Location(s): Round Lake Beach, Illinois, United States
Geographic Context:
- Round Lake Beach is located in northeastern Illinois, approximately 45 miles north of Chicago
- The area offers a mix of urban and suburban living, with access to cultural attractions, outdoor recreation, and a variety of housing options
- Illinois is known for its diverse economy, strong healthcare industry, and robust job market
Work Schedule: Monday-Friday, 8:00 AM - 4:30 PM, with potential for off-shift or weekend work as needed
ASSUMPTION: The work environment is fast-paced and dynamic, with a focus on quality, compliance, and continuous improvement.
💼 Interview & Application Insights
Typical Process:
- Online application submission
- Phone or video screen with a recruiter
- In-person or virtual interview with the hiring manager and/or team members
- Background check and reference verification
- Job offer and onboarding
Key Assessment Areas:
- Problem-solving skills and analytical thinking
- Communication and interpersonal skills
- Attention to detail and quality focus
- Understanding of regulatory requirements and compliance
Application Tips:
- Highlight relevant experience in cGMP-related industries or environments
- Demonstrate strong problem-solving skills and examples of successful NCR investigations
- Showcase knowledge of FDA regulations and international regulatory requirements
- Tailor your resume and cover letter to emphasize skills and experience relevant to this role
ATS Keywords: Non-conformance, NCR, CAPA, regulatory compliance, audit-readiness, DMAIC, process improvement, cGMP, problem-solving, analytical skills, communication skills, organizational skills, independent decision-making, Six Sigma, Lean Manufacturing, TrackWise, risk management
ASSUMPTION: Baxter uses an Applicant Tracking System (ATS) to manage job applications, so including relevant keywords in your resume and cover letter can help your application stand out.
🛠️ Tools & Technologies
- TrackWise
- Microsoft Office Suite (Word, Excel, PowerPoint)
- Quality management systems (e.g., ISO 9001, ISO 13485)
ASSUMPTION: Familiarity with these tools and technologies is beneficial for this role, as they are commonly used in manufacturing and quality management environments.
👔 Cultural Fit Considerations
Company Values:
- Patient-centered
- Integrity
- Quality
- Innovation
- Collaboration
Work Style:
- Results-driven
- Team-oriented
- Adaptable and resilient
- Attention to detail
Self-Assessment Questions:
- Do you have a strong commitment to patient care and quality?
- Are you able to work independently and make decisions with minimal oversight?
- Can you thrive in a dynamic and fast-paced environment?
- Do you have strong problem-solving skills and the ability to analyze complex information?
ASSUMPTION: Baxter values employees who are patient-centered, results-driven, and committed to quality and innovation.
⚠️ Potential Challenges
- Working in a regulated environment with strict quality and compliance requirements
- Managing multiple NCR investigations and corrective actions simultaneously
- Potential for off-shift or weekend work as needed
- Keeping up with changes in regulatory requirements and industry standards
ASSUMPTION: These challenges require strong problem-solving skills, adaptability, and a commitment to quality and compliance.
📈 Similar Roles Comparison
- Quality Engineer - Responsible for designing and implementing quality systems and processes
- Regulatory Affairs Specialist - Focuses on ensuring products comply with regulatory requirements and obtaining necessary approvals
- Manufacturing Supervisor - Oversees day-to-day manufacturing operations and ensures production goals are met
ASSUMPTION: These roles share some similarities with the NCR Writer position, but each has its unique focus and requirements.
📝 Sample Projects
- Conducting a thorough NCR investigation and implementing an effective CAPA to address the root cause of a non-conformance
- Developing and delivering training on regulatory requirements and compliance to manufacturing team members
- Participating in a process improvement project to enhance efficiency and effectiveness in the manufacturing process
ASSUMPTION: These projects demonstrate the key responsibilities and skills required for the NCR Writer role.
❓ Key Questions to Ask During Interview
- Can you describe the typical workload and priorities for this role?
- How does this role contribute to Baxter's mission of saving and sustaining lives?
- What opportunities are there for professional growth and development in this role?
- How does the company support work-life balance for employees in this role?
- What is the typical career path for someone in this role?
ASSUMPTION: Asking these questions can help you better understand the role, the company culture, and the opportunities for growth and development.
📌 Next Steps for Applicants
To apply for this position:
- Submit your application through this link
- Tailor your resume and cover letter to highlight relevant skills and experience for this role
- Prepare for interview questions related to problem-solving, regulatory compliance, and quality management
- Follow up with the recruiter one week after submitting your application to check the status of your application
⚠️ This job description contains AI-assisted information. Details should be verified directly with the employer before making decisions.
