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Documentation Specialist (Change Control)

|  Posted On: Jul 23, 2025

Des Plaines, IL 60018

5 Months, Contract

On-site

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Job Summary

Job Title:  
Documentation Specialist (Change Control)

Posted Date:  
Jul 23, 2025

Duration:  
5 Months, Contract

Shift(s):  

08:00 - 17:00


Salary ($): 
19.57 - 20.55 per Hourly (compensation based on experience and qualifications)

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Name:
 
Ankit Kemkar

Email:
 
ankitk@rangam.com

Phone:
 
847-463-3678

Description

Description

  • This onsite position is responsible for initiating and managing change control packages, primarily for device master records, to support product end-of-life documentation.
  • The change control process may involve various document types, including Manufacturing Procedures, Quality Control Procedures, Certificates of Analysis, Material Specifications, and Labels/Package Inserts.

 

Key responsibilities include:

  • Creating thorough and well-drafted change impact assessment documents.
  • Ensuring quality documents are properly redlined and in-process revisions are controlled before approval.
  • Conducting detailed reviews of document changes before submission to supervisors or approvers.
  • Ensuring all necessary documents for routing change requests are in place before approval.
  • Ensuring documentation is appropriate, justified, and approved by responsible functional areas according to timelines and established procedures.