CareersUSA, a leader in the staffing industry with over 38 years of experience, has another job opportunity for you:

Our Client is seeking a QA Document Controller in Philadelphia, PA.

Earn $14.00 to $18.00 per hour at this full-time, temp-to-hire position. Work 40 hours per week, Monday through Friday at the following schedules:

• 10:00 AM to 6:30 PM
• 12:00 PM to 8:30 PM  

Job Summary:

The QA Document Controller (QADC) prepares customer files, reviews and approves batch records and releases batch records and finished product.  The QADC acts as the primary liaison to our customer’s quality assurance groups for batch record review and release.  This position requires communication between the operations/production, project management, shipping and quality assurance groups to ascertain pertinent information relating to the contract packaging orders. 

Job Description:

• Review and approve all batch records prior to production to ensure that they conform to requirements of cGMP and clinical trial protocol
• Include review of material status, protocol conformance and clinical design layout, ensuring blinding techniques are followed
• Monitor schedule for production priorities
• Attend scheduling meetings when needed
• Review of completed batch record for conformance with protocol and appropriate cGMP and ensure that any changes are performed according to procedures
• Confirm proper randomization schedule utilization for correct patient treatment group assignment
• Be the primary liaison with client for batch release
• Communicate with other functions to resolve inconsistencies with proper recording and completion of the batch record and associated documentation. Communications may include educating other functions to ensure compliance to regulations, procedures and client requirements
• Ensure timely release of batch for protocol initiation date
• Release batch within Scheduling database
• Release batch within JDE inventory management system
• Record and track errors and not-right-first-time to maintain departmental metrics
• Archive batch documents onto shared drive and within archive room
• Ensure that responsibilities are completed efficiently while maintaining quality
• Promote a positive working environment
• Coach new QADC staff through day to day activities when needed
• Communicate SQDC counter measures and safety issues to Quality Management
• Ensure QADC metrics are met or take action to correct
• Comply with EH&S and 5S requirements for QADC
• Other tasks or projects as assigned