Manufacturing Operator II - MDI - 3rd Shift
- Dispensing rawmaterialand primary packing materials as per work order.
- Ensure the proper planning and execution of batches.
- Monitoring cleaning and sanitation of production area and machinery as per respective SOP during batch to batchand product toproduct changeover.
- Daily monitoring and recording of production materials and production lines.
- Conducting process checks and recording in batch manufacturingrecord.
- Controlling machine operations with minimum rejections and maximum outputs whilemaintainingquality standards within the standard norms.
- Operating equipment and performing necessary maintenance on machinery.
- Safeguard equipment for smooth functioning with co-ordination of engineering for preventive maintenance and calibration.
- Manufacturing andfilling ofproducts as per Batch Manufacturing Records and SOP.
- Maintaining inventory of machine parts,toolsand accessories.
- Working individually and in collaboration with others as part of a team.
- Coordinating with other departments like packaging, engineering,QAand QC for better planning and execution.
- Sampling as per schedule and in coordination with QA and QC.
- Check and ensure status labels at all stages of manufacturing and filling.
- Identifyingandassistingin any corrective actions.
- Perform,checkand ensure calibration/verification of instruments,equipmentand weighing balances as per schedule.
- Ensuring line clearance during batch to batch and product to product change over.
- Online documentation andtimelyentries related to manufacturing and filling operations and activities.
- Wearingappropriate PPEasstatedin the SOP before entering any processing areas.
- Executing 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 relatedduties asassigned.
- Maintaining 100% cGMP and SOP Compliance during complete operation hours.
- Complyingwith all company policies and procedures.
- Reporting all issues that arise to the department head or reporting manager.
- Performing daily maintenance on equipment and machinery.
- Completing all documentationin a timely manner, ensuring their integrity,accuracyand completeness.
- Maintaining discipline indepartment.
- May berequiredtoassistin the training of other employees in the department.
- Flexibleto workextended hours, to achieve manufacturing schedule when needed.
- High school diploma or equivalent isrequired.
- Accredited college certificate or university degree is preferred.
- Minimum two (2)yearof manufacturing experience with MDI or aerosol productsrequired.
- Proficient in the English language (Speaking/Reading/Writing) to understand work instructions and document results.
- Knowledge of fundamental cGMP and regulatory requirements in a pharmaceutical manufacturing environmenthighlypreferred.
- Basic understanding of mechanical machinery and the operating principles of control systems.
- Ability to follow both verbal and written instructions.
- Demonstrated ability to work in both independent and team environments.
- Good knowledge of Health & Safety procedures, including OSHA.
- Strong mathematical and organizational skills.
- This position requires the ability to do heavy lifting / bendingfrequently.
- Exert an amount of force continuously and/or up to 5 pounds of forcefrequentlyand/or up to 25 pounds of force occasionally and/or up to 50 pounds of force rarely byutilizinga hand truck to lift, carry, push, pull or otherwise move objects.
- Abilityto wearappropriate PPEis required.
- Individualmay be required to wear respiratory devices that include but are not limited to: Air Purifying Respirators (APR) which include half-face and full-face negative pressure respirators, hooded powered air purifying respirators, or Supplied Air Respirators (SAR), which include hooded orfull facesupplied air respirators.
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