Container Closure Testing Technician

The Container Closure Integrity testing laboratory analysts in the Analytical Quality Control Operations (AQCO) organization will serve as a technical resource to execute container closure test method validations and transfers, to support installation of CCIT in Quality Control testing labs, both within client and at contract partners.  The CCIT analyst has primary responsibility for executing approved protocols for method validation and transfer, generating the data necessary to complete studies, training analysts in receiving laboratories, and participating in investigations of protocol deviations or protocol execution issues.  The analyst may also participate in generating documentation, including methods, protocols, reports and change controls in support of these activities. The CCIT analyst should have familiarity with basic laboratory operations and must be capable of operating in a cGMP laboratory environment.

• Execute approved protocols for method validation and transfer, with accurate documentation of execution steps and data in an electronic notebook or other electronic execution system.

• Provide hands-on training and oversight to receiving laboratories before and during method transfers, including troubleshooting for execution difficulties.

• Assist with investigations into protocol or method execution errors or difficulties in successful testing.

• Author methods, protocols, and reports to support new molecules or transfer existing methods to new laboratories.

• Technically review validation or transfer data generated by other analysts.