cGMP Change Control Lead & Documentation Expert

Katalyst CRO; North Chicago (IL); On-site; USD 85,000 - 120,000; Full time

Job summary

Katalyst CRO in Illinois is seeking a Change Control Specialist to support change management and documentation within a cGMP-regulated analytical environment. The role centers on coordinating, managing, and tracking change control workflows across analytical methods, validation, and instrumentation.

The ideal candidate has strong experience in change management, documentation, and technical writing in GMP settings, with familiarity with QA, Regulatory, and cross-functional collaboration.

Qualifications

• Bachelor's degree in Chemistry, Biology or related field preferred.
• 3+ years of experience in a cGMP-regulated environment.
• Strong documentation and technical writing skills.
• Experience with OneTrack or TrackWise is preferred.
• Exposure to analytical testing techniques is preferred.
• Open to non-local candidates willing to relocate at own expense.

Responsibilities

• Manage and coordinate change control activities using OneTrack or similar systems (e.g., TrackWise).
• Initiate, track, manage, oversee, and ensure timely completion of change management workflows across cross-functional teams.
• Serve as the Subject Matter Expert (SME) for the OneTrack Change Management system within the department.
• Initiate change requests for commercial products and instruments and act as the project owner or initiator.
• Serve as Change Coordinator for local and global change plans.
• Work with change requestors to ensure proposals are ready for review.
• Facilitate cross-functional meetings and coordinate with stakeholders to meet project timelines and compliance requirements.
• Monitor open change requests and provide status visibility to requestors and change managers.
• Ensure compliance of change request documentation with applicable cGMP processes and procedures.
• Maintain an accurate, cGMP-compliant documentation change control system.
• Create, review, redline, and manage technical documents including SOPs, test methods, validation protocols and reports, and instrument qualification documents.
• Support documentation for method validation, method transfer, and instrument qualification activities.
• Collaborate with QA, Regulatory, Supply Chain, Analytical, and other cross-functional teams.
• Utilize Microsoft Office applications (Word, Excel, PowerPoint) for documentation and reporting.

Skills

Change management

Technical writing

Quality systems

OneTrack

TrackWise

Documentation

Cross-functional teams

Microsoft Office

Education

Bachelor's degree in science

Associate degree considered

Master's degree acceptable

Tools

OneTrack Change Management

TrackWise

SOPs

Job description

Katalyst CRO in Illinois is seeking a Change Control Specialist to support change management and documentation within a cGMP-regulated analytical environment. The role centers on coordinating, managing, and tracking change control workflows across analytical methods, validation, and instrumentation.

The ideal candidate has strong experience in change management, documentation, and technical writing in GMP settings, with familiarity with QA, Regulatory, and cross-functional collaboration.