GMP Documentation & Quality Compliance Specialist

Baxter International Inc.; Round Lake (IL); On-site; USD 49,000 - 68,000; Full time

Benefits offered by this job

Health benefits

401(k) plan

ESPP

Paid time off

Job summary

Baxter International Inc. is seeking a Documentation Specialist to support manufacturing by reviewing batch records and GMP documentation to ensure compliance with cGMP, Baxter policies, and local procedures.

You will help maintain the integrity of manufacturing records, ensuring they are complete, accurate, and ready for product release. Working closely with Manufacturing and Quality teams, you will handle documentation review processes, investigations, and document control activities to

Qualifications

• Associate degree or 3+ years of experience in a manufacturing and/or quality documentation environment.
• Experience with GMP documentation, GDP, and cGMP standards.
• Familiarity with quality systems, investigations and document control processes.

Responsibilities

• Review manufacturing batch records and GMP documentation for cGMP compliance.
• Verify records meet specifications prior to submission to Quality.
• Ensure documentation is complete and organized before batch folder submission.
• Maintain and file documentation for easy retrieval.
• Initiate and close GME work orders and NCRs as needed.
• Support GME cycle counting and continuous improvement initiatives.

Skills

Attention to detail

Microsoft Office

Verbal and written communication

Independent worker

Multitasking

Education

Associate degree

Tools

Maximo

SYSTECH

Job description

Baxter International Inc. is seeking a Documentation Specialist to support manufacturing by reviewing batch records and GMP documentation to ensure compliance with cGMP, Baxter policies, and local procedures.

You will help maintain the integrity of manufacturing records, ensuring they are complete, accurate, and ready for product release. Working closely with Manufacturing and Quality teams, you will handle documentation review processes, investigations, and document control activities to