Job Description

PRIMARY PURPOSE:

Lead a manufacturing team of Production Assemblers safely through the production process, assuring quality and efficiency standards are always achieved.

Ensure all required documentation is properly completed and in compliance with company policy and federal regulations.

MAJOR DUTIES AND RESPONSIBILITIES:

• Operate filling and packaging equipment.
• Receive production goals and requirements from the area Production Supervisor to maintain the production schedule.
• Ensure that shift start times and end times are adhered to. Report issues to the area Supervisor.
• Retrieve Batch Records and other needed documents from the quality department.
• Review all assigned Batch Records to assure your understanding. Request support or training when needed.
• Ensure all materials have been properly picked for the production order.
• Set up production line for specific production requirements and standards as directed by the batch record. This includes the mechanical assembly of some equipment.
• Review materials for correctness against the Batch Record Bill of Materials. Report discrepancies to the area Supervisor.
• Check that all assemblers are properly signed into the batch record
• Assemble Production Assembler team, discuss production process, quality attributes, and manufacturing goals.
• Assure you and all employees are using the proper PPE for the tasks that are being performed.
• Review all safety instructions in the batch record with Production Assemblers.
• Assigns personnel to cleaning and production tasks based on their training and abilities.
• Comply with all quality, safety, and company policies. Report concerns the area, Supervisor.
• Monitor quality attributes, perform quality checks as required by the batch record.
• Report quality and safety concerns to the area Supervisor. Stop production, if necessary, to ensure the safety of employees and the quality of the product being produced.
• Before, during, and after, ensure compliance with all batch record requirements is achieved.
• Document all data and tasks as required by the batch record.
• Maintain all equipment and area logs.
• Maintain the cleanliness of equipment and the area.
• Communicate with other teams, i.e., management, quality, and maintenance, as needed.

QUALIFICATION:

A. Required

• Dependable transportation.
• Can work independently or with a team.
• Speak and understand English fluidly.
• Communicate clearly verbally and in writing.
• Work shifts that may exceed 10 or 12 hours when asked.
• Work weekends.

B. Preferred Additional

• Past packaging production experience.
• CGMP, 5-S, Clean Room experience.
• Past production work experience of 5 plus years. 

CRITICAL SKILLS AND ABILITIES:

• Ability to operate complex production machinery and related equipment.
• Ability to lead, direct, and train others on tasks that will be performed.
• Ability to assist in the diagnosis and repair of malfunctioning machines.
• Ability to follow written/verbal instructions.
• Ability to keep accurate records.
• Must be able to stand in one place for the length of the shift.
• Perform basic math functions, i.e., addition, subtraction, and division. 
• Perform counts on components. 
• Place components on other components while they move on a conveyor.
• Follow written/verbal instructions.
• Write clearly and legibly. 
• Lift 35 – 50 pounds on a regular basis.
• Use of a scanner, calculator, or computer. 

COMPUTER SKILLS:

Technical Skills and Experience

• MS Outlook, Word, Excel

Education and/or Training

• High School diploma or equivalent
• Computer basics/calculator

SHIFT:

• 3rd shift, 11:00 pm - 7:30 am