Manufacturing Operators MA

Job Title: Manufacturing Operator

FLSA Classification: FullTime NonExempt/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 inprocess 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 crosstrain 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 roles responsibilities qualifications and physical demands necessary for performing manufacturing operations within a pharmaceutical environment at InvaGen Pharmaceuticals Inc.