Remedy Intelligent Staffing is seeking quality Assurance Document Control Coordinator 1st Shift near Philadelphia area
This position requires the individual to prepare customer files, review and approve batch records, and release batch records and finished product. The individual acts as the primary liaison to our customer's quality assurance groups for batch record review and release. The position requires communication between the operations/production, project management, shipping and quality assurance groups to ascertain pertinent information relating to the contract packaging orders.
Hours: 9AM -5:30PM, Monday Thru Friday
Review and approve all batch records prior to production to ensure that they conform to requirements of cGMP and Clinical Trial Protocol.
- Includes review of material status, protocol conformance, 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.
' 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.
- Weekly Pay
- Medical, Dental, Vision and Retirement Savings Plan
- Free online skill building courses
- Permanent opportunity
Military service and Veterans encouraged to Apply.
For IMMEDIATE consideration, APPLY NOW!