Softgel Operator II - 2nd Shift

Amneal

2d•Onsite

About The Position

The Softgel Operator II role is responsible for documenting activities in production batch records and log books, and for maintaining and monitoring the complete operation of the softgel encapsulation process. This position operates on the 2nd Shift, from 3:30 PM to 12:00 AM, Monday to Friday. The operator must ensure 100% cGMP and Compliance throughout all softgel operations, including in-process documentation and checks for average weight, ribbon thickness, shell weight, fill weight, and physical defects. Responsibilities also include maintaining area cleanliness, proper use of PPE, monitoring environmental conditions (temperature and humidity), reporting abnormal machine sounds, operating the encapsulation machine according to specifications, maintaining weighing scales, and ensuring optimal machine speed. The operator must stop the machine if inferior quality softgels are produced. Additionally, the role involves cleaning gelatin manufacturing equipment, assisting in the manufacture of gelatin and fill material, ensuring adequate lubricant levels, checking holding tanks, and correctly identifying gelatin types and fill materials before encapsulation. The position also requires adherence to Amneal's rules and regulations and performing other assigned duties.

Requirements

High School or GED.
2 years or more of experience in Pharmaceuticals Manufacturing with HS/GED.
3 years or more of proven related experience in Pharmaceuticals Manufacturing if less than HS/GED.
Ability to read, write, and communicate in English at an intermediate level to facilitate understanding of job terminology.
Intermediate ability to comprehend and follow written and verbal procedures or instructions.
Intermediate basic math and mechanical skills.
Intermediate ability to operate forklift and pallet movers.
Successful completion of an OSHA-compliant Respirator Fit Test.

Nice To Haves

HS Curriculum (Preferred)

Responsibilities

Document activities in production batch records and log books.
Maintain and monitor the complete operation of the softgel encapsulation machine.
Ensure 100% cGMP and Compliance during all softgel operations.
Perform in-process documentation in all Softgel operations.
Conduct in-process checks including average weight, ribbon thickness, shell weight, fill weight, and physical defects (e.g., odd shapes, leakers).
Maintain cleanliness of the encapsulation room or assigned work area and ensure proper status labeling.
Properly use Safety and Protective Gears (PPE) and adhere to the Dress Code.
Monitor room temperature and humidity as required by the product.
Inform the supervisor or designee of any abnormal machine sounds during operation.
Operate the softgel encapsulation machine according to product specifications in the batch record.
Maintain weighing scales, ensuring they are clean and checking their calibration status, reporting overdue calibrations to the supervisor.
Operate the softgel encapsulation machine at optimum speed.
Stop the machine if softgels of inferior quality are found.
Clean all gelatin manufacturing equipment, including holding tanks, homogenizers, and melting tanks, after use according to established procedures.
Assist in the manufacture of gelatin and fill material.
Ensure adequate lubricant/mineral oil level in the pump case before start-up.
Ensure the machine has adequate ribbon lubricant (MCT) before starting a batch.
Check all gelatin and active solution holding tanks before the start of a batch.
Properly identify the gelatin type and fill material/API solution before the encapsulation process.
Abide by Amneal's current rules and regulations regarding day-to-day business activities.
Perform other duties as assigned.