Manufacturing Operator - 2nd Shift

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 requested based on business needs)

Reports To: Manufacturing Supervisor

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

The scope (content and statements) of this job description is designed to describe the general nature and level of work as well as provide a basic understanding of the role, responsibilities, and expectations of the person assigned to perform the job. This job description is not designed to provide an exact or exhaustive list of all job duties, tasks, skills, and qualifications.

The intent is to give a general scope of the knowledge, skills, and abilities needed to satisfactorily perform the essential functions of the position and provide basic performance expectations. The scope of the job may be modified with respect to the department, group, and on an individual assigned basis to a sometimes-specific testing group. Consideration of education, relevant training, and experience or a combination of all three may also result in further modification of the role.

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.
• Performing 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…