Job Description

PRIMARY PURPOSE: 

• Lead a manufacturing team of Production Assemblers safely through the production process assuring quality and efficiency standards are always achieved.
• Assure 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 area Production Supervisor to maintain the production schedule.
• Ensure that shift start times and end times are adhered to. Report issues to 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.
• Assure all material have been properly picked to the production order.
• Set-up production line for specific production requirements and standards as directed by the batch record. This includes mechanical assembly of some equipment.
• Review materials for correctness against the Batch Record Bill of Materials. Report discrepancies to area Supervisor.
• Check that all assemblers are properly signed into the batch record and punched into the production order during its duration.
• Assemble Production Assembler team, discuss production process, quality attributes and manufacturing goals.
• Assure you and all employees are using the proper PPE for the task 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 to area Supervisor.
• Monitor quality attributes, perform quality checks as required by the batch record.
• Report quality and safety concerns to area Supervisor. Stop production, if necessary, to ensure the safety of employees and quality of the product being produced.
• Before, during and after assure compliance with all batch record requirements are achieved.
• Document all data and task as required by the batch record.
• Maintain all equipment and area logs.
• Maintain cleanliness of equipment and area.
• Communicate with other teams i.e. management, quality and maintenance as needed. 

QUALIFICATIONS: 

1. 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. 

1. 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 task that will be performed.
• Ability to assist in 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 length of 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 (preferred): 

Technical Skills and Experience 

• MS Outlook, Word, Excel.

Education and/or Training 

• High School diploma or equivalent.
• First aid / CPR.
• Computer basics / calculator.