Reagent Packaging Assembler

Pay Range: $15.00hr - $20.00hr

Job Overview:

The candidate will be responsible for completing set-up, assembly, packaging, and prep operations in compliance with approved documentation and QSR standards. This role involves performing routine manufacturing tasks, line clearance, routine maintenance, and proper documentation while supporting quality and continuous improvement initiatives.

Responsibilities:

• Complete set-up operations for assembly, packaging, and prep operations in compliance with approved documentation and QSR.
• Perform line clearance, equipment preventative maintenance, and routine housekeeping.
• Perform routine tasks working from detailed written or verbal instructions.
• Assemble, repair, inspect, and test products following written instructions.
• Assist engineering and maintenance teams with troubleshooting, maintenance, and equipment repair.
• Ensure the completion and accuracy of documentation associated with manufactured products and equipment maintenance.
• Clean, perform, and document routine equipment maintenance and minor repairs.
• Dispose of hazardous waste material in designated hazardous waste areas.
• Support continuous improvement activities, such as 5S and OEE.
• Support new equipment installation and validation processes.
• Assist with problem-solving related to product quality.
• 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 guidance.
• Collaborate with engineers, maintenance technicians, QC technicians, and management to implement process improvements.
• Perform semi-routine assignments requiring judgment to resolve problems and make routine recommendations.
• Maintain awareness of quality consequences, device defects, product design, verification, validation, manufacturing, and testing activities.
• Exhibit professional behavior consistent with organizational policies and build productive working relationships.

Minimum Qualifications:

• High school diploma or GED.
• 2+ years of related experience.
• Strong verbal and written communication skills.
• Ability to perform tasks requiring limited judgment in troubleshooting proven processes.
• Experience working within a quality system environment.

Preferred Qualifications:

• 3+ years of experience, preferably in medical device manufacturing.
• Experience with MS Office Suite.
• Knowledge of regulatory standards including FDA, ISO, and OSHA.
• Basic understanding of manufacturing systems, including documentation, compliance, inventory control, and production scheduling.