Visual Inspection Manufacturing Technician

Cynet Systems•Fremont, CA
•Onsite

About The Position

The candidate will execute routine unit operations in visual inspection as assigned related to the manufacturing of drug product in a multi-product facility. The candidate will perform duties under limited supervision according to standard operating procedures and adhere to established cGMP regulations.

Requirements

  • 1+ years of experience in a cGMP regulated industry.
  • Ability to concentrate on detail-oriented work in a complex technical setup with a Quality and 'Right the first-time' mindset.
  • Strong written and verbal communication skills.
  • Ability to work with computer-based systems and manufacturing execution systems (MES).
  • Ability to read and understand SOPs and instructions and document work in a written format applying cGMP standards.
  • Ability to work as part of a high-performing team and collaborate effectively with staff.
  • Ability to read and see clearly.

Nice To Haves

  • Associate's/Bachelor's degree or biotechnology vocational training preferred.

Responsibilities

  • Execute routine unit operations in visual inspection as assigned related to the manufacturing of drug product in a multi-product facility.
  • Perform duties under limited supervision and according to standard operating and manufacturing procedures.
  • Execute independently with adequate training, complex fundamental operations such as visual inspection, advanced visual inspection, palletizing, cleaning, inspection hood preparation for operations, BioMES operations, and exceptions.
  • Perform internal support duties including assisting with drug product filling and packaging.
  • Execute independently with adequate training fundamental operations including logistics coordination, batch record executions, equipment use logs, work order initiation and tracking, support projects, and supporting the creation/maintenance of training kits documents.
  • Work according to cGMP and cGDP standards, adhering to established regulations and site protocols.
  • Report abnormalities and deviations in a timely and accurate manner.
  • Adhere to safety standards, identify unsafe situations or habits, and escalate appropriately.
  • Maintain production areas according to predefined standards (5S).
  • Maintain training compliance and train other technicians and associates on operations upon completion of trainer qualification.
  • Contribute to quality activities such as supporting investigations, corrective actions, and area walkthroughs.
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