Scientist II

Location: North Chicago, Illinois | Job type: Contract | Work hours: 9 to 5

About the role

A top-tier global pharmaceutical leader is seeking a dedicated Scientist II to serve as the subject matter expert for cGMP change control and documentation systems. This high-impact role streamlines analytical workflows, driving compliance and efficiency across critical pharmaceutical development projects.

Responsibilities

• Serve as the Subject Matter Expert for OneTrack Change Management, initiating, managing, and tracking change requests for commercial products and instruments.
• Draft, redline, and maintain cGMP-compliant documentation, including SOPs, test methods, validation protocols, transfer reports, and instrument qualifications.
• Coordinate local and global change plans, collaborating directly with requestors to ensure complete, audit-ready proposals.
• Facilitate cross-functional team meetings to review pending changes, maintain project timelines, and ensure full alignment.
• Monitor open change requests, providing full process visibility to project owners and department leadership.
• Drive complete regulatory and procedural compliance across all change request documentation.

Requirements

• BS in a scientific field.
• 3+ years of experience in a cGMP-regulated environment.
• Strong documentation and technical writing skills.
• Knowledge of change management principles.
• Proficiency in a Microsoft Office environment (Word, Excel, PowerPoint).
• Excellent oral, written, and presentation skills.

Preferred Qualifications

• Hands-on experience with the OneTrack Change Management system.
• Background in analytical testing (chromatography or wet chemistry).

Skills

• Chemistry
• Chromatography
• Good Laboratory Practices (GLP)
• Good Manufacturing Practices (GMP)

Pay

$45.00 - $54.13 per hour

Benefits

• Medical, prescription, dental, and vision insurance
• AD&D and life insurance
• Short-term disability
• 401K plan (all benefits are based on eligibility)