Document Control Specialist

Collabera

Des Plaines (IL)

On-site

USD 28,929 - 37,195

Full time

14 days+

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Job summary

A leading company is seeking a Document Control Specialist to join their Technical Product Support team. This role involves managing change control packages, conducting impact assessments, and collaborating with scientists to solve technical documentation issues. Ideal candidates will have project management experience and familiarity with quality systems.

Qualifications

Experience with project management.
Familiarity with Quality Systems.
Ability to conduct technical impact assessments.

Responsibilities

Manage change control packages for device master records.
Conduct detailed reviews of changes for documents.
Assist with project management for IVDR remediation and UDI activities.

Skills

Project Management

Quality Systems

Technical Impact Assessments

Problem-Solving

Collaboration

Tools

Smartsheet

Job description

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Base pay range

$21.00/hr - $27.00/hr

Direct message the job poster from Collabera

We are seeking a dedicated Change Control Specialist to join our Technical Product Support team.
This position will be primarily responsible for initiating and managing change control packages for device master records to support product end-of-life documentation and supplier change notifications, as well as project managing various activities including product design history file IVDR remediation, UDI activities, and change packages.

Key Responsibilities:

Change Control Management: Handle various document types including Manufacturing Procedures, Quality Control Procedures, Certificates of Analysis, Material Specifications, and occasionally Labels/Package Inserts.
Impact Assessment: Create thorough and well-drafted change impact assessment documents, ensuring quality documents are properly redlined and in-process revisions are controlled prior to approval.
Document Review: Conduct detailed reviews of changes for documents before submission to supervisors/approvers, ensuring all necessary documents for routing change requests are in place.
Compliance: Ensure documentation is appropriate, justified, and approved by responsible functional areas within the timeline and in compliance with established procedures.
Project Tracking: Assist with project management for various activities including product design history file IVDR remediation, UDI activities, and change packages. Utilize Smartsheet to track project progress, ensuring timely updates and efficient management of change control activities.
Collaboration: Work with scientists to problem-solve technical documentation issues and learn the Quality System, document change control, and technical impact assessments.

Qualifications: