QA-Document Control Coordinator

The position entails Quality Assurance support to CCL Clinical Systems contract label generation operations and any additional tasks as needed to assist with day-to-day operations. This position reports directly to the Manager of Quality Assurance.

Responsibilities :

Pre-Production Phase Activity

• Initial Lot Set Report / Regimen data / Data approval prior to send for client approval created by Project Leader / Project Manager based on CSPR / Client provided info.
• Initial Assignment Set Report / Data approval
• Supplemental Data / Variable Data Approval
• Label Copy / Proof / Artwork approval
• Initial Clinical Booklet Copy / Proof approvals
• Clinical Booklet Copy / Proof approvals getting from Booklet Vendor
• Randomization, Blinding / Double Blinding info Approval

Post-production Phase Activity

Incoming materials / components

Clinical Booklet

Qualifications

Training :

Working Conditions : Clinical Systems, Inc. will provide a clean and safe work environment for all employees.

Confidentiality Statement : Based on the nature of our business, it is understood that all customer-related clinical trial data is confidential. Upon hire, each employee is required to adhere to that confidentiality.