GMP Documentation Specialist | Quality & Compliance

Baxter Healthcare; Round Lake (IL); Hybrid; USD 49,000 - 68,000; Full time

Benefits offered by this job

Health benefits

401(k) plan

Employee stock purchase plan

Paid time off 20–35 days

Job summary

Baxter is hiring a Documentation Specialist in Round Lake, IL to support manufacturing operations by reviewing batch records and cGMP/GDP documentation. You will ensure records are complete, accurate, and submitted on schedule to support product release activities.

Working closely with Manufacturing and Quality teams, you will perform document control, investigations, and process improvements. Strong attention to detail and knowledge of GMP is essential.

Qualifications

• Associate degree (or 3+ years in manufacturing/quality docs) required.
• Experience reviewing batch records and GMP documentation.
• Knowledge of GDP and cGMP practices is essential.
• Experience with quality systems, investigations, and document control.

Responsibilities

• Review batch records and GMP docs to ensure compliance with cGMP and GDP standards.
• Support batch documentation review and prepare records for Quality submission.
• Verify documentation accuracy and ensure completeness before batch release.
• Maintain organized documentation files for quick retrieval.
• Initiate and close GME work orders and NCRs as needed.
• Maintain TCU docs, revisions, and gap assessments.

Skills

Attention to detail

Independent work

Verbal and written communication

Overtime flexibility

GMP/GDP knowledge

Quality systems experience

Investigations experience

Document control

Education

Associate degree

Tools

Maximo

SYSTECH

Microsoft Office

Job description

Baxter is hiring a Documentation Specialist in Round Lake, IL to support manufacturing operations by reviewing batch records and cGMP/GDP documentation. You will ensure records are complete, accurate, and submitted on schedule to support product release activities.

Working closely with Manufacturing and Quality teams, you will perform document control, investigations, and process improvements. Strong attention to detail and knowledge of GMP is essential.