Job Description

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 includes manufacturing products in the clean room environment.

This position includes significant duties such as:

Ensures 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 days’ 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 palletizes finished product in accordance with plant deadlines

Provide input to new, and revising existing, SOP’s 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

Ensures 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

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 perform work in a clean room environment.

Education: High School