Utilize dispensing systems, scales, and balances to accurately weigh, dispense, and label raw materials for manufacturing.Prepare partial raw material containers for return to the warehouse and properly deface and dispose of empty raw material drums in accordance with current SOPs.Verify the accuracy of all materials delivered from the Dispensing area and all in-process materials received from prior manufacturing operations, following established SOPs.Perform granulation and compounding activities, including the setup, operation, and monitoring of manufacturing equipment.Perform tablet compression and capsule filling operations, including the setup and operation of equipment such as:
- Tablet Presses
- Capsule Fillers
- Dedusters
- Metal Detectors
- Disintegration Testers
- Friabilators
- In-Process Weight Check Systems
- Hardness Testers
- Micrometers
Maintain compression and encapsulation tooling, including receipt, measurement, storage, inventory control, and issuance of required tooling.Perform film coating operations, including the setup and operation of equipment such as:
- Coating Pans
- Solution Tanks
- Spray Guns
- Mixers
Maintain a clean and safe work environment and perform room and equipment cleaning activities as required.Conduct room and equipment inspections and complete all associated documentation accurately.Clearly and accurately complete all required GMP documentation, batch records, and manufacturing records.Adhere to all cGMP requirements, regulatory standards, SOPs, batch records, protocols, and company policies.Comply with all Health, Safety, and Environmental (HSE) regulations, policies, and procedures.Wear and properly utilize all required Personal Protective Equipment (PPE) in accordance with company policies and procedures.Complete all required training programs and maintain training compliance.Report operational issues and manufacturing activities to manufacturing management as required.