Manufacturing Operators (MA)

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

Reports To: Facilities Operations Manager

Purpose: This role serves as a Manufacturing Operator for metered dose inhalation (MDI) products at InvaGen Pharmaceuticals, Inc.'s Fall River, MA site.

Scope: This job description provides an overview of the general nature of work, responsibilities, and expectations for the position, though not exhaustive in detail.

Job Description

The Manufacturing Operator performs duties essential to the production of MDI products, ensuring compliance with Current Good Manufacturing Practices (cGMP), customer requirements, and Standard Operating Procedures (SOP). Responsibilities include:

• Dispensing raw materials and primary packing materials as per work order.
• Planning and executing batches efficiently.
• Monitoring and maintaining cleanliness of production areas and equipment during changeovers.
• Daily monitoring, recording, and reporting of production activities.
• Conducting in-process checks and recording results in batch manufacturing records.
• Operating and maintaining machinery to achieve production goals with minimal rejections.
• Coordinating with engineering for preventive maintenance and calibration.
• Filling products according to Batch Manufacturing Records and SOP.
• Managing inventory of machine parts, tools, and accessories.
• Collaborating with packaging, engineering, QA, and QC departments for effective production planning.
• Sampling and coordinating with QA/QC as scheduled.
• Ensuring accurate labeling and documentation throughout manufacturing and filling stages.
• Assisting in identifying and implementing corrective actions.
• Conducting calibration and verification of instruments and equipment as scheduled.
• Ensuring line clearance during changeovers.
• Documenting operations and activities promptly and accurately.
• Adhering to SOPs and wearing appropriate PPE in processing areas.
• Executing tasks safely and efficiently according to Health & Safety protocols and equipment manuals.
• Performing other duties as assigned.
  
  

Other Responsibilities

• Maintaining 100% cGMP and SOP compliance throughout operations.
• Adhering to company policies and procedures.
• Reporting issues promptly to department heads or managers.
• Performing daily equipment maintenance.
• Completing documentation accurately and timely.
• Upholding discipline within the department.
• Assisting in training new employees.
• Flexibility to work extended hours as needed to meet production schedules.
  
  

Training And Safety

All employees undergo initial and ongoing training. Operators may cross-train in various manufacturing areas. Adherence to safety, health, and environmental guidelines is mandatory during all operations.

Qualifications

• High school diploma or equivalent required.
• Advanced vocational training or education preferred.
• Minimum one (1) year of manufacturing experience with MDI or aerosol products.
• Proficiency in English (speaking, reading, writing) for understanding instructions and documenting results.
• Familiarity with cGMP and regulatory requirements in pharmaceutical manufacturing.
• Basic mechanical understanding and control system operation.
• Ability to follow verbal and written instructions.
• Demonstrated ability to work independently and in teams.
• Knowledge of Health & Safety procedures, including OSHA regulations.
• Strong mathematical and organizational skills.
  
  

Physical Requirements

• Ability to lift heavy objects and bend frequently.
• Use of hand trucks and exertion of varying amounts of force.
• Wear appropriate PPE, including respiratory devices when required.
  
  

This job description outlines the role's responsibilities, qualifications, and physical demands necessary for performing manufacturing operations within a pharmaceutical environment at InvaGen Pharmaceuticals, Inc.