Title: Manufacturing Operator II
Location: Fremont, CA 94538
Duration: 12 months
Shift time: Day shift, 6:00 AM to 2:45 PM, Monday through Friday, or as assigned. Overtime, including after hours and weekends, may be required based on production needs
Pay rate: 22.00/hr. on W2
Description:
About the Role
This role supports diagnostic kit manufacturing at our Fremont, CA site in a cGMP-regulated environment. The position works with DEA-controlled substances (Schedules I to V) and requires strict compliance with DEA, FDA, and Client standards.
What You'll Do
Follow Manufacturing SOPs and Quality System requirements
Complete production records accurately, including weights, times, dates, and in-process entries
Operate production equipment such as conveyors and adjust speeds as needed
Perform quality checks and help troubleshoot issues
Work with the team to meet daily production Clients
Requirements
High school diploma or equivalent
Basic computer skills (Microsoft Word and Excel)
Careful attention to detail when filling out paperwork
Willing to learn and follow written procedures
Experience in manufacturing, a lab, or a similar hands-on setting
Experience working in a regulated environment (cGMP, FDA)
Packaging, kitting, or assembly experience preferred.
Physical Requirements and Work Environment
Able to lift up to 40 lbs
May work in cold areas and around loud equipment
Must wear required PPE, including lab coat, gloves, safety glasses, and ear protection
Must follow all safety and regulatory procedures for handling Schedule I to V materials