Solid Dose Manufacturing
Summary/Objective
Primarily responsible for manufacturing of controlled oral solid dose products according to Master Batch Records
Essential Functions
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
1. Responsible for the set-up, operation and cleaning a tablet presses and bulk accountability throughout compression processes
2. Identify and report quality issues
3. Must be in compliance at all times by following batch records, SOPs and all company policies
4. Perform all in-process testing and inspections as required by the Master Batch Record (i.e. weighing, tablet thickness, tablet hardness, friability, visual inspection, etc.)
5. Cleaning and sanitization of manufacturing rooms including walls, floors, and ceilings per current SOPs
6. Report accidents and unsafe conditions or unusual circumstances to supervisor.
7. Responsible for following Current Good Manufacturing Practices (cGMP)
8. Responsible for maintaining a neat and orderly work area at all times
9. Other duties, which may be assigned from time to time, by management of the company
Supervisory Responsibility
This position is Non-Management
Work Environment
This job operates in a production/manufacturing environment. This role routinely uses standard office equipment such as computers.
Physical Demands
1. Ability to lift 50 pounds
2. Ability to stand for long periods of time (8-10 hrs. a day, 4-6 days a week)
3. In accordance with FDA regulations (21CFR 211.68), individual must be free from illness that could jeopardize the safety or quality of products. Such illnesses may include, but are not limited to, illnesses that cause bleeding, open lesions, flaking or peeling skin.
Position Type/Expected Hours of Work
This is a full-time position. Days and hours of work are Monday through Friday; 6:00 a.m. to 2:30 p.m. Occasional evening and weekend work may be required as job duties demand.
Travel
No travel required
Preferred Education and Experience
1. High School Diploma or GED.
2. Previous compression/ machine operator experience in manufacturing.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
