Job Description

No supervisory responsibilities.

Essential Duties and Responsibilities

• Responsible for efficiently and safely handle and operating any pharmaceutical packaging equipment in order to complete packaging of all incoming products, in accordance with standard operating procedures and cGMP compliance.

• Setup the packaging line and prepare the machine for packaging per Batch Record.

• Startup and close down of their machine as necessary

• Efficient completion of final assembly and then packaging processes

• Fill machine hopper with required bottles, caps, cans and tubes.

• Fill product using appropriate equipment as stated on Batch Record.

• Inspect and remove any defective components from the packaging line.

• Inspect and remove the filled product from the packaging line.

• Fold individual boxes and package product as per instructions from Supervisor/QA Inspector.

• Package finished products in shipper box and apply shipper box label.

• May be required to move completed boxes of products.

• Maintaining cleanliness of equipment and work area

• Reporting issues when they arise – this should be done quickly to minimize any impact on the efficiency of production

• Quality checks of their equipment, process or product in accordance with the site’s quality requirements.

• Place completed shipper box on a pallet. (Approximate weight up to 30 lbs.)

• Move completed pallets from packaging area to warehouse using a pallet jack.

• Operate packaging line. Inform the Supervisor or Maintenance Department if required.

• Clean packaging line, machine parts and packaging rooms.

• Must be in compliance at all times by following batch records, SOPs and all company policies.

• Identify and report quality issues.

• Report accidents and unsafe conditions or unusual circumstances immediately to the Supervisor or Manager.

• Understand and adhere to all cGMP and FDA regulations.

• Responsible for maintaining a neat and orderly work area at all times.

• Ability to work on first and/or second shift, some weekends as well as overtime when required.

Additional Job Responsibilities

• Other duties may be assigned occasionally, as needed by management.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Ability to read, comprehend and apply comprehensive knowledge of pharmaceutical cGMPs, SOP’s, Batch Records and training documents to ensure ongoing quality compliance.

• Ability to perform all requirements independently with limited managerial oversight.

• Superior attention to detail to ensure accuracy of work product.

• In accordance with FDA regulations, Packaging Employee must be free from illness that could jeopardize the safety or quality of products. Such illness may include but are not limited to any contagious illness, a condition that causes bleeding, open lesions, flaking or peeling skin.

• Must be able to wear all types of required protective equipment.

Education and/or Experience

• Has a high school diploma or the equivalent.

• Previous experience in a pharmaceutical manufacturing & packaging environment is preferred.

LANGUAGE SKILLS

• Must be able to read, understand and clearly communicate in the English language or with the minimal assistance of an interpreter.

• Ability to effectively present

  information and respond to questions from Supervisor.

MATHEMATICAL SKILLS

• Ability to accurately perform mathematical calculations, including:

• Addition, subtraction, multiplication and division.

You should be proficient in:

• Material Handler Experience