Title: Manufacturing Operator - Solid Dosage
Location: Hauppauge or Central Islip, New York.
Duration: Full Time
Job Summary
This position is a Production Operator assigned to support coating. This is an hourly labourer and individual contributor role that will report to a Front-Line Supervisor. This position may be based at the Company’s manufacturing units in Hauppauge or Central Islip, New York.
There are two shifts available:
1st Shift 07:00 am - 03.30pm ( 3 positions)
2nd Shift 03:00 pm - 11:30 pm ( 3 positions)
Job Responsibilities:
· Person must be able to know how to operate pharmaceutical production machinery independently.
· Execute procedures for manufacturing processes in accordance with batch manufacturing record (BMR) and Standard Operating Procedures (SOP) requirements.
· Perform machine changeovers, cleaning and set up as per SOPs. Ensure the proper area & equipment cleanliness and setup in stipulated time.
· Prepare a room and equipment for line clearance, replace room filters, Ensure verification and calibration of balance/scale and check pressure differential for the rooms.
· Ensure line clearance before initiating manufacturing activities in each area.
· Receive/transfer material from/to dispensing/manufacturing storage and check dispensed materials/final mix blend/compressed tablets and labeling as per BMR.
· Wear appropriate personal protective equipment (PPE) as stated in the SOP/BMR before initiating process.
· Able to operate applicable equipment independently as per area of operation.
· Troubleshoot and make appropriate adjustments to equipment to maintain product/BMR specifications.
· Ensure adherence to quality standards during all stages of the manufacturing process.
· Complete manufacturing documents on time, ensuring accuracy and completeness.
· Responsible for training on all relevant SOPs and always maintain compliance with related SOPs and current Good Manufacturing Practices (cGMP) in the manufacturing process.
· Perform duties through the proper, safe use of equipment, according to Health & Safety procedures and Equipment Manuals.
· Flexible to work extended hours, to achieve manufacturing schedule when needed.
· Should maintain discipline and comply with company policies and procedures.
· Should perform entire duties as communicated time to time by department management/designee.
Minimum Requirements:
· Solid mechanical aptitude and troubleshooting skills.
· Minimum of 2 years of experience working in industrial environments such as pharmaceutical manufacturing and related settings.
· Must have excellent communication skills.
· Must be able to clearly communicate in English (verbally and in writing).
· Positive, professional attitude toward work and willingness to cooperate with co-workers and supervisors.
· Must be able to work different shifts as per organizational requirement and should be flexible for working additional hours such as overtime and weekends.
Physical Requirements
· Should not have any restriction to work with powder containing active pharmaceutical ingredients.
· This position requires the ability to do heavy lifting / bending frequently.
· Long periods of standing up/walking during the working hours; ability to ascent/decent ladders; and able to lift to 35 pounds.
· Must be able to move pallets/equipment weighing about 200 – 300 kgs using suitable moving equipment like pallet jacks.