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.

 

Qualifications

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

• Assists with Batch Record review of printed Labels
• Disposition/ Release of printed labels
• Issuance of Certificate of Compliance (C of C) or Certificate of Material Compliance (C of MC)
• JMS System Release of the Batch

 

Incoming materials/components

• Inspection/ Testing of incoming materials/components as per Specification
• Disposition/ Release of incoming materials/components upon full compliance with Specification
• IMS System Release of the batch

 

Clinical Booklet

• Initial Clinical Booklet Copy/ Proof review and approvals against client supplied proof prior to sending to Client
• Vendor Clinical Booklet Copy/ Proof review and approvals through Global Vision
• Vendor Clinical Booklet Copy/ Proof review and signed approvals sent to vendor

 

Qualifications

• Minimum of 1 year of relevant experience
• Ability to proofread printed material and check written documentation.
• Ability to follow detailed verbal and written instructions.
• Full knowledge of cGMP regulations and operational SOPs.
• Advanced mathematical skills and grammatical knowledge.
• Advanced computer skills.
• Excellent analytical skills.
• Excellent organizational skills.
• Excellent communications skills.

 

 

Training:

• cGMP training
• SOP training
• On the job training
• Prior experience

 

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.