A Top-Tier Global Pharma Leader in North Chicago, IL 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.
location: North Chicago, Illinois
job type: Contract
salary: $45.00 - 54.13 per hour
work hours: 9 to 5
education: Bachelors
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.
qualifications:
- Required:
- 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:
- 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)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
