Change Control Specialist

About the Role

A non-laboratory position focused on coordinating, managing, and tracking change control processes related to analytical methods, validation, and instrumentation within a cGMP-regulated environment.

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.

Requirements

• 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.
• 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.