POSITION PURPOSE AND SCOPE:This position is responsible for encapsulating various products using an encapsulation machine. Encapsulation is a moderately technical position within a clean room environment.
ESSENTIAL RESPONSIBILITIES:- Understands and follows all GMPs and SOPs and refers to them on a daily basis.
- Notes and reports any SOP/GMP deviations to supervisor.
- Reports any respiratory, personal illness, open sores, or infections to supervisor.
- Practices general good hygiene and standards of personal grooming.
- Maintains good housekeeping by keeping area clean and sanitary.
- Completes the specified steps for correct gowning for each entry into production areas and clean rooms.
- Follows all procedures that apply to the operation and completes documentation entries in an accurate and timely manner.
- Keeps production records and logs current.
- Records necessary information on MBR.
- Verifies all drums and components coming in and going out for appearance, lot number, item number, description and correct quantities.
- Monitors machine operation to detect product defects and/or machine malfunction.
- Must ensure encapsulated product is kept within required tolerances.
- Trouble shoot problems related to product quality and machine performance.
- Reads job specifications and determines machine adjustments and material requirements.
- Accurately complete all paperwork, including log sheets, machine reports, MBR, SPC charts and clean-up logs.
- Performs minor machine maintenance such as routine lubrication of cams and bearings.
- Performs efficient clean ups within GMP/SOP regulations with quick turn-around time.
- Works closely with production supervisor in training of new operators when needed.
- Must be detail oriented and be able to follow very specific instructions.
- Must be flexible and willing to change schedule in order to meet production needs as well as cross-train with other departments as needed.
- PPE equipment will be used appropriately and at appropriate times.
- Follows all safety rules regarding the manufacturing area and in production line support.
- Operates forklift as needed.
Note: This description is not intended to be all-inclusive. Employer may be requested to perform other duties as requested.
EDUCATION EXPERIENCE:High school diploma or equivalent required plus 1-2 years work experience in production with nutraceutical or pharmaceutical environment preferred.
PHYSICAL DEMANDS:The employee may be required to lift and/or move up to 75 lbs on a regular basis and occasionally more. Long hours standing, sitting, bending, twisting, walking.
WORK ENVIRONMENT: This is a manufacturing environment which includes loud noise levels for extended periods of time, long hours standing, sitting, bending, twisting, walking, climbing stairs, strong odors, confined spaces, warm and cold temperatures, wet/slippery and slick surface environment. The employee is regularly required to lift and/or move up to 75lbs and occasionally more. Employees working in this position are required to wear a dust mask. The employee regularly works near moving mechanical parts and is regularly exposed to fumes or airborne particles. The employee occasionally works in high, precarious places. The employee is regularly required to talk or hear and use hands to finger, handle or feel objects, tools, or controls. Specific vision abilities required by this job include close vision. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
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