Documentation & Change Control Specialist

Baxter Healthcare; Town of Ridgeway (NY); On-site; USD 61,000 - 83,000; Full time

Job summary

Baxter Healthcare is seeking a Documentation Associate I to support document and change control activities for timely product releases. You will review, process, maintain, and file controlled documents and assist with audits and process improvements.

You will manage Iron Mountain/Records 365 archival, support daily document controls, and contribute as a SME on governance & compliance tasks in a manufacturing environment.

Qualifications

• High school diploma or equivalent required.
• Two (2) or more years’ experience with Product Data Management / documentation systems or equivalent change control systems.
• Proficient with computers and in the use of Microsoft Office Suite.
• Experienced in document, data, and product configuration management, including change control.
• Strong verbal / written communication and problem-solving skills.
• Strong attention to detail with the ability to independently organize workload, perform under strict deadlines and changing priorities with minimal supervision.
• Ability to handle multiple tasks concurrently.
• Ability to communicate with all levels within the organization.
• Able to demonstrate responsiveness to customer needs, within job scope.
• Knowledge of Food & Drug Administration (FDA) Regulations and application of Good Manufacturing Practices.

Responsibilities

• Review documentation for accuracy and compliance with procedures; release or reject as appropriate.
• Ensure all document and system elements are correctly identified, accurate, and assembled for review and approval.
• Author/Own internal documents as related to the Document Control Department.
• Serve as a focal point for document control, change control processes/procedures, issues, or inquiries.
• Provide coaching for new Change Control Management Owners and Approvers.
• Communicate change status to originators and provide guidance to alternate documentation personnel.
• Provide backup support for other document personnel.
• Maintain Facility Employee Signature Files.
• Serve as the Iron Mountain/Records 365 Administrator/SME. Manage/maintain Redbooks.
• Document Number Assignment.
• Generate Inspection Checklist (ICL) for Manufacturing.
• Maintain Document Filing and Archiving.
• Office Supply Purchase Requests.
• Provide administrative and other support such as document requests and copier maintenance.
• Provide guidance and backup to the Documentation Clerk.
• Preparation, Scanning, Verification and Archival of Device History Records (DHRs).
• Perform other duties as assigned.

Skills

Document control

Change control

Product data management

Microsoft Office

Communication

Attention to detail

FDA regulations

Audits support

Multitasking

Education

High school diploma

Tools

Iron Mountain

Records 365

Document filing systems

Job description

Baxter Healthcare is seeking a Documentation Associate I to support document and change control activities for timely product releases. You will review, process, maintain, and file controlled documents and assist with audits and process improvements.

You will manage Iron Mountain/Records 365 archival, support daily document controls, and contribute as a SME on governance & compliance tasks in a manufacturing environment.