Description
Operators are responsible for operating special purpose machines or industrial equipment to specifications on production basis in typical oral solid dose pharmaceutical manufacturing. Processes include dispensing and weighing of materials, using automatic and semi-automatic equipment for tablet manufacturing, combining materials to make blends and solutions, and packaging of finished product.
Essential Responsibilities
- Ensure the proper set-up and operation of standard pharmaceutical process equipment such as Granulators, Blenders, Mills, Table Presses, Tablet Coaters and Packaging.
- Ensures proper execution of Master Batch Records, standard operating procedures and validation protocols.
- Ensures accurate completion of equipment logs and/or lab notebooks.
- Ensures cleanliness and proper assembly of manufacturing equipment per approved procedures (SOP’s).
- Weighs out material and components for production batches.
- Interfaces and consults with Analytical Sciences and Quality Assurance personnel.
- Understands and adheres to all cGMP and FDA regulations.
- Performs other duties as assigned or requested
Core Competencies
- Excellent written and verbal communication skills.
- Ability to read and comprehend SOP’s, Batch Records and training documents.
- Ability to multi-task effectively
- Excellent interpersonal skills and ability to effectively interact with different functional groups.
Minimum Qualifications
- High School Diploma or equivalent or technical school certificate
- 1-3 years solid dose production operator experience or previous experience working in a regulated manufacturing environment (GMP or FDA), such as food and chemical processing facilities.
Physical Requirements
- Must be able to stand for an 8 hour shift and lift, push or pull up to 50 pounds.
- Ability to wear any type of protective equipment
The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.