Manufacturing Technical Writer

📍 Location: Round Lake, IL

💰 Estimated Salary: $48,000 – $66,000 per year

🕘 Full-Time | On-Site

Position Overview

This position plays a key role in supporting high-quality manufacturing operations by ensuring documentation and compliance align with current regulatory standards. As a Manufacturing Technical Writer, you will be responsible for investigating non-conformances, implementing corrective and preventive actions, and supporting audit-readiness across the plant.

Key Responsibilities

• Lead non-conformance investigations using the TrackWise 8 Management System
• Implement corrective and preventive actions (CAPAs) linked to investigations
• Maintain expert knowledge of regulatory compliance and industry standards
• Act as a compliance resource for plant teams and ensure audit-readiness
• Provide guidance on DMAIC problem-solving and process improvement initiatives
• Ensure adherence to internal procedures, U.S. and international regulations, and corporate quality standards

Qualifications

• Bachelor’s degree in science, engineering, or a related field
• 2–4 years of experience in a cGMP-regulated industry or clinical environment
• Strong analytical and problem-solving skills
• Excellent written and verbal communication skills
• Ability to work independently with minimal supervision
• Greenbelt certification or experience with Six Sigma or Lean Manufacturing tools preferred
• Proficient in TrackWise
• Working knowledge of FDA and international regulatory requirements
• Familiarity with risk management tools
• Flexibility to support off-shift or weekend work as needed

Work Environment & Culture

• Dynamic, collaborative work environment focused on continuous improvement
• Emphasis on professional development, mentorship, and cross-functional teamwork
• Mission-driven culture with a focus on improving lives through quality manufacturing

Compensation & Benefits

• Competitive salary commensurate with experience
• Eligible for discretionary bonuses
• Comprehensive benefits package includes:
• Medical, dental, and vision coverage starting on day one
• Life, accident, and disability insurance
• 401(k) with company match
• Employee Stock Purchase Plan (ESPP)
• Paid time off, holidays, and parental leave
• Flexible Spending Accounts, educational assistance, and childcare benefits
• Commuter support and Employee Assistance Program (EAP)

This is an ideal opportunity for a detail-oriented professional passionate about quality, compliance, and supporting life-saving manufacturing operations. Candidates must be authorized to work in the U.S. Sponsorship is not available for this role.