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Manufacturing Operators

3 months ago

Fall River, United States Unizontechnology Full time
Job DescriptionJob Description

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.