Assembler I

Title: Assembler I
Location: Pomona , CA
Hours: Mon - Fri | 6:00 AM - 2:30 PM

Description:

Seeking an Assembler I with 25 years of manufacturing experience in assembly, filling, packaging, or production, preferably in medical device, pharmaceutical, biotech, or food manufacturing environments. Experience with GMP/QSR documentation, work orders, quality systems, equipment setup, troubleshooting, and packaging/filling operations is highly preferred. Must have strong attention to detail, basic computer and Excel skills, the ability to stand for extended periods, and work effectively in a fast-paced manufacturing environment.

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)

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 companys 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.

MINIMUM QUALIFICATIONS | EDUCATION/EXPERIENCE:

• High school diploma or GED
• 2-5 years related experience
• Basic communication and written skills
• Assignments require limited judgement in troubleshooting proven processes.
• Will perform job in a quality system environment

PREFERRED QUALIFICATIONS:

• 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.)