Job Summary:
The Manufacturing Associate is responsible for day-to-day manufacturing tasks, which include manufacturing products in the cleanroom environment, ensuring adherence to company procedures and cGMP standards, and contributing to the efficient and safe operations of the manufacturing facility.
Key Responsibilities:
• Manufacture products according to company procedures and cGMP standards to achieve customer satisfaction and meet company schedules/deadlines
• Understand aseptic techniques to operate inside Class 1,000 and Class 100 cleanroom areas and other controlled environments
• Perform quality inspections on incoming and outgoing materials and products
• Sort and place materials or items on racks, shelves, or bins according to predetermined inventory procedures
• Complete batch records accurately and on time following daily production requirements
• Formulate, finish, manufacture, and fill all products produced at the plant with minimal guidance
• Monitor equipment, performing basic equipment maintenance and cleaning activities
• Record readings from laboratory and manufacturing equipment
• Follow work instructions provided by supervisor or plant leadership
• Move stacks of crates from freezer to packaging area using hand trucks/dollies
• Inspect and package products, checking for damaged bottles, labels, and heat shrinks that do not meet established standards
• Label, bag, box, and palletize finished products in accordance with plant deadlines
• Provide input to new and revise existing SOPs to ensure procedures are accurate, up-to-date, and in compliance with current Good Manufacturing Practices
• Report quality and safety issues to immediate supervisor
• Ensure personal training documentation is up-to-date and assist in training others as needed
• Maintain the organization and cleanliness of production areas
• Perform special assignments and other responsibilities as required
Required Qualifications:
• High School Diploma or GED
• 1-3 years of experience in FDA-regulated environments preferred
• Experience with aseptic techniques and cleanroom operations
• Ability to work independently and manage time efficiently
• Basic knowledge of manufacturing processes and quality control measures
Preferred Qualifications:
• Experience with Good Manufacturing Practices (cGMP)
• Familiarity with equipment monitoring and maintenance tasks
• Strong organizational skills with the ability to prioritize tasks effectively
• Strong attention to detail and commitment to quality