Documentation & Change Control Specialist

Zvh; United States; On-site; USD 61,000 - 83,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Paid holidays

Paid time off

Employee stock purchase plan

Employee discounts

Job summary

Baxter is seeking a Documentation Associate I to support document and change control activities, ensuring accurate product and system releases. You will review, process, and file controlled documents while assisting audits and process improvements across the documentation function.

The role covers administration of Iron Mountain/Records 365, training, and backup support for the Documentation Clerk, in a manufacturing FDA-regulated setting.

Qualifications

• Experience with Product Data Management or documentation systems.
• Knowledge of FDA regulations and GMP.
• Able to maintain documentation accuracy and regulatory compliance.
• Strong attention to detail and organizational skills.
• Ability to work under deadlines and manage multiple tasks.

Responsibilities

• Assist with document and change control activities to ensure timely product releases.
• Review documentation for accuracy and compliance; release or reject as appropriate.
• Serve as focal point for document control and change control processes.

Skills

Document control

Data management

Change control

Verbal & written communication

Microsoft Office

Attention to detail

Time management

Education

High school diploma or equivalent

Tools

FDA regulations

ISO/CFR knowledge

Job description

Baxter is seeking a Documentation Associate I to support document and change control activities, ensuring accurate product and system releases. You will review, process, and file controlled documents while assisting audits and process improvements across the documentation function.

The role covers administration of Iron Mountain/Records 365, training, and backup support for the Documentation Clerk, in a manufacturing FDA-regulated setting.