Documentation Specialist

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.

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.

• 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.

• 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.
• Ability to lift up to 30 pounds.
• 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

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $49,600 - $68,200 annually. The estimated range is meant to reflect an anticipated salary range for the position.

We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based upon…