Operator Packaging - 3rd shift

Cosette Pharmaceuticals, Inc. is a US-based, fully integrated pharmaceutical company with capabilities in product development, manufacturing, and commercial operations. Cosette has a fast-growing portfolio of branded pharmaceuticals consisting of products in the cardiology, women's health, and migraine markets. Cosette has a long history in quality manufacturing of complex dosage forms including topical creams, ointments, oral liquids/solutions and suppositories, which has led to consistent supply to customers and commercialization success. Cosette has corporate and manufacturing facilities in New Jersey and North Carolina and is supported by more than 300 dedicated employees across all functional areas.

Innovating every day.

Essential Functions and Responsibilities

• Perform filling and packaging operation
• Verify line clearance, bulk product and literature to prevent product/literature mix-up
• Operate and set up filter, cartoner and labeller and accurately perform all quality checks and documentation per company SOP's, SOF's and cGMP's
• Release line by following all process instructions, completing documentation, and performing accurate calculations in the packaging records
• Perform all functions on a line in a changeover and make minor adjustments to equipment
• Complete final packaging record documentation accurately before it is turned into the packaging office
• Participate in the training of operators
• Must perform filling and packaging inspection duties accurately and efficiently. Perform line start up/clean up procedures and complete related documentation
• Demonstrate mastery of all equipment safety features including the ability to start and stop all filling and packaging equipment
• Learn to recognize and report any safety concerns by initiating a "Safety Near Miss" form (if applicable) and implement corrective action(s)
• Learn to recognize and report any product quality-related deficiencies
• Product waste removal and disposal
• Maintain a clean and orderly work environment
• Other duties assigned by management.

Education/Training/Work Experience

• High School diploma or equivalent preferred and/or relevant work experience

Specialized Knowledge and Skills

• Ability to operate multiple lines
• Demonstrates initiative, ownership, and problem-solving skills to make line improvements in the areas of quality, efficiency, and safety

Equipment and Applications

• Various pieces of filling and packaging equipment, including but not limited to fillers, cartoners, bundlers, case packers, tape machines, motorized and manual pallet jacks, pallet lifts

Work Environment and Physical Demands (List required PPE's)

• Required to don proper GMP gowning and PPE prior to entering production areas
• GMP gowning includes lab coat with sleeves worn at wrist level and all snaps connected, hairnet, beard cover (if applicable), procedure mask, and gloves, both are required when working over any open product or componentry
• Safety Glasses must be worn while inside of all production rooms
• Ability to withstand repetitive work
• Ability to stand for long periods of time with a moderate amount of bending and/or stretching
• Ability to lift up to and including 25 lbs on a regular basis and up to 40 lbs on occasion
• Ability to pay close attention to detail while performing required duties

Equal Opportunity Employment

Providing "equal employment opportunity" is one of the most important people policies of Cosette Pharmaceuticals, Inc. Our goal is to do all that we realistically can to provide genuine equal employment opportunity to applicants and employees in all phases of our operation. It is the policy of this Company that there shall be no discrimination with respect to employment, or any of the terms and conditions of employment, because of an individual's race, creed, religion, color, national origin, citizenship, ancestry, age, gender identity or expression, affectional or sexual orientation, marital status, domestic partnership, familial status, atypical hereditary cellular or blood trait, disability (including AIDS and HIV infection), genetic information, liability for service in the United States armed forces or any other legally protected status. The Company is dedicated to ensuring that all employment decisions are in accordance with these principles of equal employment opportunity.