Experience Needed:
- 1-3 years' experience preferred in the following:
- Experience in FDA regulated environment
- Experience aseptic techniques and working in cleanroom
The purpose of this position is:
The Manufacturing Associate will be responsible for the day-to-day manufacturing tasks which include manufacturing products in the clean room environment.
This position includes significant duties such as:
• Ensure all scheduled products are manufactured according to company procedures and cGMP's to achieve customer satisfaction and conformance to company schedule/ deadlines.
• Understands the concepts of aseptic technique to operate inside Class 1,000 and Class 100 cleanroom areas as well as other controlled areas.
• Performs quality inspections on incoming and outgoing materials and products.
• Sorts and places materials or items on racks, shelves, or bins according to predetermined inventory procedures needed.
• Completes batch records in an accurate and timely manner following each day’s production.
• Formulates, finishes, manufactures and fills all products produced at the plant with minimal guidance.
• Monitors equipment and completes basic equipment maintenance and cleaning activities.
• Utilizes and records readings from laboratory and manufacturing equipment.
• Closely follows work instructions provided in writing or verbally by supervisor/plant leadership.
• Moves stacks of crates from freezer to packaging area with hand truck/dolly to complete work.
• Inspects and packages product by checking for damaged bottles, labels and/or heat shrinks that do not meet established standards.
• Labels, bags, boxes and palletizers finished product in accordance with plant deadlines.
• Provide input to new, and revising existing, SOPs to ensure procedures are accurate, up to date and in compliance with current Good Manufacturing Practices.
• Responsible for reporting quality and safety issues to immediate supervisor.
• Ensure personal training documentation is up to date and aid in the training of others as needed.
• Maintain organization and cleanliness of production areas.
• Special assignments and other responsibilities as required.
• Use of cleaning products in an industrial environment.
• Familiarity with GDP (Good Documentation Practices).
Working Conditions:
Frequently lifts and/or moves up to 25 pounds and up to 60 pounds occasionally; rarely lifts over 60 lbs. Use of noxious or hazardous chemicals with appropriate PPE. Protective clothing or equipment may occasionally be required including gloves, freezer jacket or jumpsuit, protective eyewear, footwear. May work in a clean room environment.
Will work with the following resources:
** Transports incoming and outgoing materials to designated areas utilizing appropriate tools/vehicles to accomplish task including but not limited to hand dolly, forklift, electric dolly, pallet jack **
** Role includes use of a respirator.
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