JOB DESCRIPTION
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POSITION:
Solid Dose Manufacturing Technician I DEPARTMENT:
Solid Dose Manufacturing REPORTS TO:
Manufacturing Supervisor IMPLEMENTATION DATE
01/30/2023
SUMMARY / OBJECTIVE The Solid Dose manufacturing technician is responsible for cleaning, setting up and operating the production room and various manufacturing equipment and associated paperwork. The technician is responsible for ensuring that
manufactured batches are manufactured following cGMP guidelines and completed in a timely manner to ensure that the production schedule is met.
ESSENTIAL FUNCTIONS
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Prepares production room equipment for operation:
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Preparing equipment for operation (i.e., Granulators, Blenders, Coater, and other associated machines and measuring devices)
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Cleaning manufacturing room and equipment prior to and after use
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Check weighing materials
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Lifting and scooping material.
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Documenting production and production process.
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Operating Requirements:
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Following batch record and related SOP's.
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Setup the manufacturing equipment and ancillary equipment
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Following step by step processing instructions
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Follows cGMP's.
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Having all work checked by second person as it is done
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Documenting all work in batch record
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Performing and documenting various adjustments and measurements of machines during the production run
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Perform final review of a completed batch record
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Will work with supervision
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Preform appropriate cleaning of room and equipment after completion of manufacturing
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May be assigned other tasks below as necessary.
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Assist in revising production SOPs as needed
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Responsible for identifying problems with the equipment and deficiencies are resolved and completed.
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Cross trained to work in a second area i.e. Blending and Granulations, Dispensing, Tablet coating.
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Provide project support in the areas of manufacturing and equipment design and operation.
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Assist in the troubleshooting, tear-down, repair, refurbishment, overhaul, assembly, testing, and calibration of manufacturing equipment
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Assists in the executing of IQ/OQ/PQ protocols on all manufacturing equipment.as needed.
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Assist in the training of new manufacturing personnel.
JOB DESCRIPTION
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WORK ENVIRONMENT
The employee will be working in a dusty and/or wet environment most of the time. This job position is in a manufacturing environment and uses company supplied uniforms. The primary environment will be ambient room temperature, production lighting and exposure to various types of manufacturing equipment such as Granulators, Blenders, Metal detector, and weighing scales. The performance of this position requires exposure to manufacturing areas where personal protective equipment (PPE) such as safety toed shoes, safety glasses, hearing protection and PAPR (Powered Air Purifying Respirator) etc. are mandatory. Job requires standing for extended periods of time. Walking, primarily on a level surface, periodically throughout the day is also required. Reaching above shoulder height, below the waist and/or lifting and scooping is required to fill hoppers of the tablet press throughout the process. Proper lifting techniques required. Activities may include occasional lifting up to fifty (50) pounds of materials.
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Will be required to stand for long periods of time. Ability to operate material handling equipment. This job requires the need to be able to lift to fifty (50) pounds on a regular basis.
POSITION TYPE/EXPECTED HOURS OF WORK This is a full-time position. Days and hours of work are Monday through Friday, 6:00 am to 2:30 pm or 2:00 pm to
10:30 pm but extended (earlier or later) work times or weekend work may be required.
REQUIRED EDUCATION AND EXPERIENCE
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Operate material handling equipment
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Ability to follow written instructions
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Simple math
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Ability to lift 50 pounds
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Attention to detail
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Good organizational skills.
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Ability to recognize and solve problems
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Time management ability to handle multiple concurrent projects.
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Mechanically inclined
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Dependable
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Ability to get along with all employees
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Works with little supervision
PREFERRED EDUCATION AND EXPERIENCE
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High School Diploma/GED
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1 to 3 yrs. of pharmaceutical experience
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Demonstrates a high level of organization in task management
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Demonstrates a systematic approach to problem solving & troubleshooting
WORK AUTHORIZATION/SECURITY CLEARANCE (IF APPLICABLE)
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Authorized to work in the United States