Documentation Specialist

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.

What You'll Be Doing

• 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.

What You'll Bring

• 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