Production and Industrial - Operator II, Manufacturing

Operator II, Manufacturing
Thermo Fisher Scientific | Niche Diagnostics Division (NDX) | Fremont, CA


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 Thermo Fisher standards.


Assignment Details
Temporary assignment of about 12 months
Employed and paid through the contracted staffing supplier, and not eligible for Thermo Fisher employee benefits


Schedule
Days, 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


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 targets


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


Preferred
Experience in manufacturing, a lab, or a similar hands-on setting
Experience working in a regulated environment (cGMP, FDA)


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


EEO:


"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."