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.