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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.
Job Responsibility
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
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
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
What we offer
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)
401(k) Retirement Savings Plan (RSP)
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