Packaging Operator

Job Description:

The Packaging Operator performs all functions relating to the packaging of MDI products; consistent with established Current Good Manufacturing Practices (cGMP), customer requirements and in conjunction with all Standard Operating Procedures (SOP). Incumbents in this position are responsible for the safe and efficient execution of their job duties, while ensuring product compliance to established standards.

Essential Duties and Responsibilities:

Understanding basics of mechanical machinery and principles of control systems.

Operating pharmaceutical packaging equipment with minimum rejection and maximum output maintaining quality standard within standard norms.

Cleaning machines and area as per batch to batch and product to product change over.

Performing operations and preventative maintenance of machines.

Identifying and assisting in the corrective actions of packaging related issues.

Correcting status labelling at all stages of packing line with signature.

Ensuring that appropriate equipment calibrations are performed, and records are maintained.

Ensuring line clearance before initiating packaging activities in each area.

Wearing appropriate PPE as stated in the SOP before initiating the process.

Working individually and in collaboration with others as part of a team.

Executing procedures to complete tasks in a safe and efficient manner.

Completing documents on time, ensuring accuracy and completeness.

Adhering to all cGMPs, compliance/regulatory mandates and quality requirements.

Complying with company policies and procedures.

Performing duties through the proper safe use of equipment, according to Health & Safety procedures and Equipment Manuals.

Performing other related duties as assigned.

Other Responsibilities:

Maintaining 100% cGMP & Compliance during complete operation hours.

Must follow the Departmental SOPs.

Reporting all issues that arise to the department head or reporting manager.

Performing daily maintenance on equipment and machinery.

Maintaining discipline in department.

May be required to assist in the training of other employees in the department.

Flexible to work extended hours, to achieve manufacturing schedule when needed.

Training and Safety:

All employees must undergo various training activities at the start of their employment. New training and re-trainings will occur periodically. Employees must strictly adhere to all safety, health, and environmental guidelines at all times and ensure that all safety precautions are being taken during handling of machines.

Qualifications:

High school diploma or equivalent is required.

Accredited college certificate or university degree is preferred.

Minimum of one (1) year experience in packaging operations preferred.

Proficient in the English language (Speaking/Reading/Writing) to understand work instructions and document results.

Knowledge of fundamental cGMP and regulatory requirements in a pharmaceutical manufacturing environment highly preferred.

Basic understanding of mechanical machinery and the operating principles of control systems.

Ability to follow both verbal and written instructions.

Demonstrated ability to work in both independent and team environments.

Good knowledge of Health & Safety procedures, including OSHA.

Strong mathematical and organizational skills.

Physical Requirements:

This position requires the ability to do heavy lifting / bending frequently.

Exert an amount of force continuously and/or up to 5 pounds of force frequently and/or up to 25 pounds of force occasionally and/or up to 50 pounds of force rarely by utilizing a hand truck to lift, carry, push, pull or otherwise move objects.

Ability to wear appropriate PPE is required.

Individuals may be required to wear respiratory devices that include but are not limited to: Air Purifying Respirators (APR) which include half-face and full-face negative pressure respirators, hooded powered air purifying respirators, or Supplied Air Respirators (SAR), which include hooded or full face supplied air respirators.