Study Manager I, Extractable and Leachable

SGS • Fairfield, NJ

5h • $65,000 - $90,000

About The Position

The Study Manager I, E&L will manage and coordinate projects for extractable and leachable (E&L) testing, including writing and reviewing study protocols and reports.
Review testing results and compliance with quality criteria in accordance with cGMP. Write/review study reports; Solve questions and comments of the reports from the clients.
Design the E&L studies and write/review study protocols.
Work as a technical contact to coordinate extractable and leachable (E&L) projects with clients. Arrange and follow the projects; communicate promptly to solve technical problems as needed.
Review testing results and compliance with quality criteria in accordance with cGMP. Write/review study reports; Solve questions and comments of the reports from the clients.
Design the E&L studies and write/review study protocols.
Work as a technical contact to coordinate extractable and leachable (E&L) projects with clients. Arrange and follow the projects; communicate promptly to solve technical problems as needed.

Requirements

• Bachelor’s degree in Chemistry or related science.
• 2 years of Extractable and Leachables (E&L) project experience with protocol and report writing experience
• Knowledge of HPLC/MS and/or GC/MS and/or ICP/MS analytical instrumentation
• Excellent oral and written communication skills including grammar and composition
• Familiar with the common MS Office applications.
• Ability to work well with people of diverse backgrounds.
• Proven project management skills and a strong attention to detail.
• Have excellent interpersonal skills.
• Previous GMP experience

Responsibilities

• Manage and coordinate projects for extractable and leachable (E&L) testing
• Write and review study protocols and reports
• Review testing results and compliance with quality criteria in accordance with cGMP
• Write/review study reports
• Solve questions and comments of the reports from the clients
• Design the E&L studies and write/review study protocols
• Work as a technical contact to coordinate extractable and leachable (E&L) projects with clients
• Arrange and follow the projects
• Communicate promptly to solve technical problems as needed

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level