Job Title: Manufacturing Operator

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

Work Location: Fall River, MA

Work Hours: First Shift: 8 AM – 5 PM (may vary based on business needs) and 2nd Shift ( 3:00 PM – 11:30 PM

Must haves:

Minimum of 1 year experience in cGMP and regulatory requirements in a pharmaceutical manufacturing environment.
Minimum successful completion of High school diploma.
Basic understanding of mechanical machinery and the operating principles of control systems.
Ability to follow both verbal and written instructions including SOP’s and Batch Record documentation.
Demonstrated ability to work in both independent and team environments.
Good knowledge of Health & Safety procedures, including, OH&S Act.
Mandatory Drug Screening Required.
Job Description:

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.

Essential Duties and Responsibilities:

•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 in 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 co-ordination 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.

• On-line 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.

Other Responsibilities:

• Maintaining 100% cGMP and SOP Compliance during complete operation hours.

• Complying with all company policies and procedures.

• Reporting all issues that arises 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.

Job Type: Full-time

Pay: $17.00 - $21.00 per hour

Expected hours: 40 per week

Experience level:

• 2 years
• 3 years
• 4 years

Schedule:

• 8 hour shift
• Monday to Friday

Language:

• English (Preferred)

Ability to Commute:

• Fall River, MA 02720 (Required)

Ability to Relocate:

• Fall River, MA 02720: Relocate before starting work (Required)

Work Location: In person