Manufacturing Operator II - Ist Shift

Job Title
:
Manufacturing Operator II

FLSA Classification
:
Full-Time, Non-Exempt/Hourly Professional

Work Location
:
Fall River, MA

Work Hours: First Shift: 7:00AM - 3:30PM (May vary based on business needs)

Reports To
:
Production Supervisor

Salary Range
: $20 - 27/hr

The purpose of this role is to assist in manufacturing metered dose inhalation (MDI) products in a pharmaceutical manufacturing company.

This job is a multifunctional role. The primary nature of this job is to serve as a Manufacturing Operator. As a secondary requirement, this position will be expected to provide support to other operational functions to include but not limited to Warehouse Operations, Packaging Operations, and Facilities Operations.

The Manufacturing Operator performs all functions relating to the production 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.

• Dispensing raw material and primary packing materials as per work order.
• Ensure the proper planning and execution of batches.
• Monitoring cleaning and sanitation of production area and machinery as per respective SOP during batch to batch and product to product changeover.
• Daily monitoring and recording of production materials and production lines.
• Conducting process checks and recording in batch manufacturing record.
• Controlling machine operations with minimum rejections and maximum outputs while maintaining quality standards within the standard norms.
• Operating equipment and performing necessary maintenance on machinery.
• Safeguard equipment for smooth functioning with coordination of engineering for preventive maintenance and calibration.
• Manufacturing and filling of products as per Batch Manufacturing Records and SOP.
• Maintaining inventory of machine parts, tools and accessories.
• Working individually and in collaboration with others as part of a team.
• Coordinating with other departments like packaging, engineering, QA and QC for better planning and execution.
• Sampling as per schedule and in coordination with QA and QC.
• Check and ensure status labels at all stages of manufacturing and filling.
• Identifying and assisting in any corrective actions.
• Perform, check and ensure calibration/verification of instruments, equipment and weighing balances as per schedule.
• Ensuring line clearance during batch to batch and product to product change over.
• Online documentation and timely entries related to manufacturing and filling operations and activities.
• Wearing appropriate PPE as stated in the SOP before entering any processing areas.
• Executing procedures to complete tasks in a safe and efficient manner.
• Performing duties through the proper safe use of equipment, according to Health & Safety procedures and Equipment Manuals.
• Performing other related duties as assigned.

• Maintaining 100% cGMP and SOP Compliance during complete operation hours.
• Complying with all company policies and procedures.
• Reporting all issues that arise to the department head or reporting manager.
• Performing daily maintenance on equipment and machinery.
• Completing all documentation in a timely manner, ensuring their integrity, accuracy and completeness.
• 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.

All employees must undergo various training activities at the start of their employment. New training and re-training will occur periodically. Operators may be required cross-train in all areas of the manufacturing operations. 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.

• High school diploma or equivalent is required.
• Accredited college…