Assembler I

Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities. Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices; build productive internal/external working relationships.

Title: Assembler I
Location: Pomona, CA
Shift: 06:00 AM - 02:30 PM
Pay: $20 per hour

Description:

• Very detailed work.
• Will use master flex- set it up and give volume to fill. Have a guideline to reference.
• Lots of paperwork- basic knowledge of GMP, filling and packaging reagents
• Basic math
• Lifting no more than 15 lbs
• On feet all day- Rotating through tasks throughout the day.

The position of Assembler I is within our CMI business unit located in California. Under general supervision, the scope of this position is responsible for setting up and performing adjustments to equipment used in support of manufacturing. Ability to diagnose and perform routine technical troubleshooting is required.

Responsibilities:

• May be tasked with completing set-up operations for one of the following: assembly, packaging and prep operations in compliance with approved documentation, and QSR. This will include but not limited to line clearance, equipment preventative maintenance and housekeeping
• Performs routine tasks working from detailed written or verbal instructions.
• Assembles, repairs, inspect and/or test products following written instructions.
• Assist the Engineering and Maintenance teams with trouble shooting, maintenance, and repair of equipment
• May be tasked with the completion and accuracy of documentation associated with the manufactured product and equipment maintenance
• May be tasked with cleaning, performing and documenting routine equipment maintenance and minor repair
• Disposes hazardous waste material on corresponding hazardous waste areas.
• Required to support continuous improvements activities, (e.g. 5S and OEE, etc.)
• Support new equipment installation and validation
• May be required to assist with problem-solving related to product quality
• Ability to read and comprehend basic instructions and other work related documents.
• Demonstrate strong customer service skills while maintaining product Quality
• Participate in root cause analysis and implement corrective actions under the guidance of Supervisor or Manager
• Collaborates with Engineers, Maintenance Technicians, QC Technicians and Management to identify and help implement process improvements
• Works on assignments that are semi-routine in nature where judgment is required in resolving problems and making routine recommendations
• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices; build productive internal/external working relationships
• Carries out duties in compliance with established business policies
• Other duties as assigned, according to the changing needs of the business

Required skills:

• 2-5 yrs Assembling, filling and packaging reagents experience. No blueprints experience needed.
• Someone for pharma would be ideal but not required. As long as they have some packaging experience and can read work orders.
• Food environment experience also acceptable
• Software skills- minimal excel, basic computer skills
• Most documentation is printed out and written (not digital)

Minimum Qualification:

• High school diploma or GED
• 0+ years related experience
• Basic communication and written skills
• Assignments require limited judgement in troubleshooting proven processes.
• Will perform job in a quality system environment
• 3 years’ experience preferable in medical device manufacturing
• MS Office Suite experience
• Knowledge of regulations (FDA, ISO, OSHA, etc.)
• Basic understanding of manufacturing systems (documentation, compliance, inventory control, production scheduling/ controls, etc.)