Change Control Specialist

Change Control Specialist

We are seeking a Change Control Specialist to support change management and documentation activities within a cGMP-regulated analytical environment. This is a non-laboratory role focused on coordinating, managing, and tracking change control processes related to analytical methods, validation, and instrumentation. The ideal candidate will have strong experience in change management, documentation, and technical writing within GMP environments, along with an understanding of analytical testing and regulated workflows.

Roles & 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.

Education & Experience:

• Bachelor's degree (BS) in a scientific field such as Chemistry, Biology, or a related discipline (preferred).
• Associate degree with significant relevant experience may be considered.
• Master's degree candidates are acceptable; however, relevant hands-on experience is prioritized.
• Minimum 3+ years of experience in a cGMP-regulated environment.
• Strong experience in Change Management / Change Control.
• Strong documentation and technical writing skills.
• Knowledge of change management principles.
• Experience in QA/QC or documentation-focused roles is preferred.
• Experience with OneTrack Change Management is preferred; TrackWise or similar systems are acceptable.
• Exposure to analytical testing techniques (chromatography, HPLC, GC, wet chemistry) is preferred but not required.
• Background in method validation, method transfer, or analytical documentation is preferred.
• Strong computer proficiency in Microsoft Office (Word, Excel, PowerPoint).
• Good oral, written, presentation, organizational, and project team collaboration skills.
• Candidates with analytical laboratory experience and a strong interest in transitioning to documentation/change management may also be considered.
• Open to non-local candidates willing to relocate at their own expense.

Katalyst Healthcares & Life Sciences