Documentation Specialist

Baxter International Inc. • Round Lake, IL

1d • $49,000 - $68,000 • Onsite

About The Position

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. Your role at Baxter As a Documentation Specialist, you will provide critical support to manufacturing operations by reviewing batch records and GMP documentation to ensure compliance with current Good Manufacturing Practices (cGMP), Baxter policies, and local procedures. You will help maintain the integrity of manufacturing documentation by ensuring records are complete, accurate, and submitted on schedule to support product release activities. This is where your attention to detail and commitment to quality will directly impact operational efficiency and regulatory compliance. Working closely with Manufacturing and Quality teams, you will support documentation review processes, investigations, and document control activities that help ensure the safe and effective production of Baxter products.

Requirements

• Associate degree or 3+ years of experience in a manufacturing and/or quality documentation environment.
• Must not be allergic to Penicillin or Cephalosporin drugs.
• Proficiency with Microsoft Office applications.
• Strong attention to detail and organizational skills.
• Ability to work independently and manage multiple priorities.
• Effective verbal and written communication skills.
• Flexibility to work overtime or adjusted schedules based on business needs.
• Experience reviewing batch records and GMP documentation.
• Knowledge of cGMP and Good Documentation Practices (GDP).
• Experience with quality systems, investigations, and document control processes.
• Experience using Maximo, SYSTECH, or similar manufacturing systems.
• Continuous improvement mindset with strong problem-solving skills

Responsibilities

• Review manufacturing batch records and other GMP documentation to ensure compliance with cGMP requirements, company policies, and local SOPs.
• Support manufacturing batch documentation review and ensure records meet specifications prior to submission to Quality.
• Verify batch documentation complies with Good Documentation Practice (GDP) standards.
• Determine document acceptability using specifications, procedures, and established standards.
• Ensure all required documentation is complete and present prior to batch folder submission.
• Maintain documentation files to ensure records are organized, readily available, and easily retrievable.
• Initiate and close GME work orders.
• Author Non-Conformance Records (NCRs) and exception investigations.
• Author and maintain TCU documentation, including revisions, periodic reviews, and gap assessments.
• Utilize Maximo to print, assign, and track preventative maintenance work orders to completion.
• Use SYSTECH to review and approve batch counts.
• Initiate batch folders through required system data entry activities.
• Support GME cycle counting activities as required.
• Identify opportunities for continuous improvement and support additional administrative duties as assigned.

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
• Time-off benefits such as paid holidays
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree