cGMP Change Control Lead - Analytical Documentation

Creative Solutions Services, LLC; North Chicago (IL); On-site; USD 85,000 - 120,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a Change Control Specialist to manage change management and documentation in a cGMP-regulated analytical environment. The role focuses on coordinating and tracking change control processes for analytical methods, validation, and instrumentation.

The ideal candidate has 3+ years in change management, strong documentation skills, and familiarity with OneTrack, TrackWise, and regulated workflows.

Qualifications

• Minimum 3+ years in a cGMP-regulated environment.
• Strong experience in Change Management / Change Control.
• Excellent documentation and technical writing skills.
• Familiarity with QA/QC or documentation-focused roles is preferred.
• Exposure to analytical testing techniques is a plus.

Responsibilities

• Coordinate change control activities across cross-functional teams.
• Serve as SME for OneTrack Change Management system.
• Initiate change requests and oversee project timelines.
• Ensure change documentation complies with cGMP processes.
• Create and revise SOPs, test methods, validation protocols, and reports.
• Collaborate with QA, Regulatory, Supply Chain, and Analytical teams.
• Provide status updates to stakeholders and management.
• Utilize Word, Excel, and PowerPoint for documentation and reporting.

Skills

Change management

Documentation

Technical writing

OneTrack/TrackWise

cGMP

Microsoft Office

QA/QC

Analytical testing

Education

BS in Chemistry/Biology or related

Associate degree with relevant experience

Master's degree (acceptable)

Tools

OneTrack Change Management

TrackWise

Job description

Creative Solutions Services, LLC is seeking a Change Control Specialist to manage change management and documentation in a cGMP-regulated analytical environment. The role focuses on coordinating and tracking change control processes for analytical methods, validation, and instrumentation.

The ideal candidate has 3+ years in change management, strong documentation skills, and familiarity with OneTrack, TrackWise, and regulated workflows.