Manufacturing Operator

Job Title: Manufacturing Operator 1
FLSA Classification: Full-Time, Non-Exempt/Hourly Professional
Work Location: Fall River, MA
Work Hours: First

Shift: 7:00 AM – 3:30 PM (Flexibility is requested based on business needs)
Reports To: Manufacturing Supervisor

Salary Range: $18 - $29

The purpose of this role is to be part of 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 (Meted doses inhaler) 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 and checking of raw material and primary packing materials.
• Ensure the proper planning and execution of batches.
• Perform cleaning and sanitation of production area and machinery as per respective procedures.
• Daily monitoring of production performance.
• Perform manufacturing processes and document activities in batch records and logbooks.
• Machine operation with minimum rejections and maximum outputs while maintaining quality standards within the standard norms.
• Operating equipment and performing necessary maintenance on machinery.
• Ensure equipment upkeep in co-ordination with engineering for preventive maintenance and calibration.
• Maintaining inventory of machine parts, tools and accessories.
• Working individually and in collaboration with others as part of a team.
• Collaborate with packaging, maintenance, quality teams for cross functional activities.
• Ensure status labelling at all stages of manufacturing, filling and cleaning.
• Identifying and assisting in any corrective actions.
• Perform, check and ensure calibration/verification of instruments, equipment and weighing balances as per schedule.
• Perform line clearance checks.
• Wearing appropriate PPE as stated in the SOP before entering any processing areas.
• Following 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 assigned.
• Be able to operate computer systems with ease.
• Knowledge of pharmaceutical manufacturing and related documents.
• Basic understanding of deviation, CAPA, change control, FMECA , OOS, OOT and OOAC.

• Maintaining and followed 100% cGMP, GDP 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.

All employees must undergo various training activities at the start of their employment. New trainings and re-trainings 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 precaution are being taken during handling of machines.

• High school diploma or equivalent is required.
• Accredited college certificate or university degree is preferred.
• Minimum one (1) year of manufacturing experience in pharmaceutical…