Location: Brookhaven,NY, USA
Description:
Softgel Operator II must be able to document activities in production batch records and log books. Must maintain and monitor complete operation of softgel.
Essential Functions:
* Maintain 100% cGMP and Compliance during complete operation of softgel encapsulation. Responsible for in-process documentation in all Softgel operations
* Responsible for In-Process checks like average weight, ribbon thickness, shell weight, fills weight, physical defects like odd shapes leakers etc. Responsible for area cleanliness of the encapsulation room or assigned place of work and for proper status labeling
* Proper usage of Safety and Protective Gears (PPE) and Dress Code.
* To monitor the Room temperature and Humidity where ever the product demands. To inform any abnormal sounds coming from the machine when the machine is in running condition to the supervisor or his designee. To run the softgel encapsulation machine as per the product specifications which are written in the batch record. To maintain the weighing scales neat and clean to check the calibration status. If the calibration status is out of due date need to inform the supervisor.
* To run the softgel encapsulation machine at the optimum speed. To stop the machine if softgels are found to be of inferior quality. Clean all gelatin manufacturing equipment including holding tanks, homogenizers and melting tank after use as per established procedures. To assist in the manufacture of gelatin and fill material.
* To ensure the level of lubricant/mineral oil level in pump case is adequate before start-up. Make sure the machine has adequate ribbon lubricant (MCT) before starting batch. Checking of all gelatin and active solution holding tanks. before Start of the Batch. To properly identify the gelatin type and fill material/API solution before encapsulation process.
Additional Responsibilities:
* To abide by the Amneal's current rules and regulations regarding day to day business activities
* Other duties as assigned.