Directs and coordinates the packaging and or cartooning operation in accordance with Noven Pharmaceuticals Inc. SOPs and cGMP standards. The Lead Manufacturing Operator will set up, operate and change over packaging and or cartooning production equipment on the shift to which they are assigned. An LMO will assure that quality and documentation standards are maintained to ensure product compliance.

• Assure work center operates safely to produce products within established quality standards within the cGMP and SOP guidelines.
• Perform all set-ups and operate the machine in the prescribed area of responsibility.
• Assure the work center performs safely at a manufacturing rate consistent with established operating standards.
• Recognize and envelop quality assurance and maintenance into a comfortable routine operating team.
• Report to the shift supervisors all significant variances to quality and operating standards.
• Train employees within the work center for which he/she is responsible.
• Ensure documentation is completed and meet the prescribed standards.
• Ensure communication with oncoming shift LMO of any and all problems experienced during manufacturing.
• Assist maintenance technicians as directed by shift supervisor.
• Promote teamwork and a goal-oriented environment.
• Proficient operation/set up of packaging and cartoning machinery.
• Must meet medical requirements for personal protective equipment (PPE) used in manufacturing.
• Able to train/assist entry level LMOs.
• Able to assist senior LMO (Lead Machine Operator) in identifying minor mechanical problem with the equipment.

Competencies:

Education / Experience:

High school diploma with 1 year experience in a packaging operation or 3 years experience in a packaging environment in lieu of educational requirement Candidate must demonstrate mechanical aptitude, ability to speak, read and write in the English language, basic computer skills and demonstrate the ability to perform basic mathematical calculations.

Judgment / Decision Making:

Ability to ascertain that work complies with approved standards and meets the prescribed guidelines of Noven Pharmaceuticals Inc. Must demonstrate leadership qualities and work under moderate supervision. Employee must demonstrate the ability of adhering to stringent documentation requirements.

Work Environment:

Plant floor, pharmaceutical products.

Physical Demands:         

The employee is occasionally required to climb, balance, stoop, kneel, and crouch. Must demonstrate the ability to lift and or move 50 pounds or greater.