Encapsulation Operator

Role Overview

The Encapsulation / Tablet press Operator is responsible for the operation and set-up of capsule filling machine in accordance with company standard operating procedures (SOP’s) and cGMP’s regulations to ensure products meet applicable quality standards. This position includes set-up, operation, cleaning, and light mechanical adjustments. The Encapsulation/ Tablet press Operator is accountable for overall production line performance including safety, quality, shrink, attainment, and line efficiency. Operators must be capable of operating multiple like machines at one time and learning to operate a variety of equipment within the manufacturing area.

Areas of Responsibility

• Performs machine cleaning, changeovers and set up as required while maintaining a clean working environment.
• Ensures full compliance with Company policies, procedures, GMP’s, Ethical Business Practice, and SOP’s at all times. Ensures documentation such as operation logs, batch records, etc. are fully completed, signed and in compliance with company standards and regulatory requirements.
• Utilizes problem-solving skills to investigate and troubleshoot product issues and recommend solutions for:

1) encapsulation issues such as denting, splitting, capsule not entering the magazine or rectifier block, capsule not getting loaded, capsule non-separation, target weight not achieved or weight variation, not closing properly

2) general issues such as machine set-up, machine performance, and documentation

• Ensures that product meet applicable quality standards. This includes inspection for quality during operation and performing all required sampling and testing.
• Perform start-ups and reconciliation before, during, and after batch is completed.
• Takes samples of product and perform in process testing as per batch record instructions.
• Reviews batch records for accuracy and completeness, correctly documenting all steps.
• Observe machine operation; makes adjustments as needed; inspect machine for wear and tear and report any issues to supervisor.
• Inform supervisor/manager of any discrepancies during production and stop production and segregate product not in compliance.
• Coordinates with supervisor to enhance productivity and quality.
• Performs all material handling of product and components.
• Trains new encapsulation workers on SOP’s, cGMP's, and the operation of processing equipment from start to finish.
• Participates in any investigation for a deviation involving a batch record.
• Maintains proper gowning and hygiene to ensure integrity of the product as per cGMP’s and ensure that all other safety standards are in place.
• Fills in appropriate logbook for equipment and rooms.
• Perform processing room cleaning as needed.
• Works extended hours and occasional weekend overtime.
• Other duties as assigned.

Other Responsibilities Including Safety:

• Works in a safe and responsible manner to create an injury-free and incident-free workplace.
• Complies with all job-related safety and other training requirements.
• Keeps management informed of area activities and of any significant problems.

Requirements

Education & Qualification:

• High school graduate or GED equivalent
• 3 years Encapsulation Operator experience
• Minimum of one (1) year work experience in nutritionals, supplements, food, or pharmaceutical manufacturing industries.
• Must have at least 5 years of encapsulation experience within a pharmaceutical production environment.
• Additional experience in granulation, compression, or blending is a strong plus.

Skills & Ability

• Demonstrates ability to work in a team and assist others.
• Able to follow written instructions precisely and perform basic math calculations as required.
• Understands and is knowledgeable of cGMP, OSHA standards, etc.
• Demonstrates the ability to read and write basic English to be able to understand the industry-regulated instruction sheets.
• Demonstrates forklift experience with both sit-down and stand-up trucks.

Physical Requirements (lifting, etc.):

• Ability to lift up to 50 lbs.; occasionally lift and move up to 75 pounds.
• Must stand and walk on the production floor for a minimum of 6 hours per shift.
• Uses hands to finger, handle, feel, or operate objects or controls, lifting to waist height and/or above shoulder height, frequent bending from the waist, or squatting, walking short distances.
• Occasionally works from a rolling ladder or step stool, must be to lean over equipment as well as kneeling on the floor to clean under the equipment.
• Must be able to wear all PPE including a lab coat, face mask, booties, gloves, safety glasses/goggles, and respirators.

Work Environment (Office, Warehouse, temperature extremes, etc.):

• Work is regularly performed inside a manufacturing environment where temperatures can be moderate, exposure to dust, odors, noise, and fumes. The noise level is usually moderate.

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship.

Job Type: Full-time

Pay: $20.00 - $28.00 per hour

Benefits:

• Health insurance

Schedule:

• 8 hour shift

Work Location: In person

Salary : $20 - $28