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Operator

6 months ago

Marietta, Georgia, United States LanceSoft Inc Full time

Use proper aseptic technique while performing tasks in the Grade A/B areas to include bulk formulation vial filling routine and non-routine aseptic interventions operating filling and autoloading equipment using automated control systems unloading of autoclaves and management of sterilized components.

Operate processing equipment by SOPs in all classified areas (Grade A/B/C).

Actively participate in troubleshooting processes and equipment problems as well as assisting the supervisor in completing all necessary paperwork associated with investigations deviations and remarks.

Use proper aseptic technique while performing tasks in the Grade A/B areas to include filling line routine aseptic interventions (pulling of samples EM monitoring & clearing downed vials) non-routine aseptic interventions (filler setup needle changeout) operating filling and autoloading equipment using automated control systems; perform automatic weight checks; assist with and performs non-routine interventions without compromising the aseptic environment.

Actively participate in the creation and revision of batch records standard operating procedures protocols and all other GMP documents.

Troubleshoot process equipment and interact with maintenance personnel Demonstrate proficiency as outlined in training requirements for equipment systems and position.

Responsible for loading