Manufacturing Quality & Regulatory Writer

Baxter International Inc.; Round Lake (IL); On-site; USD 64,000 - 88,000; Full time

Benefits offered by this job

Medical and dental coverage starting day one

401(k) Retirement Savings Plan with company matching

Paid parental leave

Flexible Spending Accounts

Educational assistance programs

Commuting benefits

Job summary

A leading healthcare technology company in Round Lake, Illinois is seeking a Manufacturing Technical Writer to ensure adherence to quality and compliance standards. The candidate will handle investigations and contribute to manufacturing processes while mentoring team members. This role demands strong analytical and communication skills, along with relevant experience in a regulatory setting. Competitive salary and comprehensive benefits offered.

Qualifications

• 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.
• Available to work during off-shift or weekends as needed.

Responsibilities

• Perform non-conformance (NCR) investigations within the Track Wise 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.
• Mentor on DMAIC problem-solving and process improvement projects.

Skills

Strong problem-solving and analytical skills

Excellent written/verbal communication and organizational skills

Greenbelt certification or equivalent experience using Six Sigma

Experienced user of TrackWise

Understanding of risk management tools

Education

BS/BA in science, engineering, or related field

Tools

TrackWise

Job description

A leading healthcare technology company in Round Lake, Illinois is seeking a Manufacturing Technical Writer to ensure adherence to quality and compliance standards. The candidate will handle investigations and contribute to manufacturing processes while mentoring team members. This role demands strong analytical and communication skills, along with relevant experience in a regulatory setting. Competitive salary and comprehensive benefits offered.