Manufacturing Technical Writer

About the position

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.

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.

Requirements

• BS/BA in science, engineering, or related field.
• 2-4 years of relevant work experience in a cGMP-related industry or clinical setting.
• 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.
• Available to work during off-shift or weekends as needed.

Benefits

• Medical and dental coverage that start on day one.
• Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance.
• Employee Stock Purchase Plan (ESPP) with the ability to purchase company stock at a discount.
• 401(k) Retirement Savings Plan (RSP) with options for employee contributions and company matching.
• Flexible Spending Accounts.
• Educational assistance programs.
• Paid holidays and paid time off ranging from 20 to 35 days based on length of service.
• Family and medical leaves of absence.
• Paid parental leave.
• Commuting benefits.
• Employee Discount Program.
• Employee Assistance Program (EAP).
• Childcare benefits.